Summary
Overview
Work History
Education
Skills
Timeline
Generic

Smita Abhang

Edison,USA

Summary

Extensive experience in medical information and drug safety with increased responsibilities in technical and supervisory tasks. Well-versed in the pharmacovigilance process and all aspects of clinical trials. Ensured a high level of client satisfaction throughout all phases of assigned projects. Ability to communicate effectively with business professionals, scientists, and colleagues. Detailed oriented work ethics, good verbal communication Enthusiastic, hard-working team player looking to impact growth, development and success of US Drug safety and Pharmacovigilance.

Overview

34
34
years of professional experience

Work History

Senior Safety Specialist

Thermo Fisher Scientific- CRG
11.2021 - Current
  • Responsible for overall coordination of Serious Adverse Event (SAE) processes for designed projects
  • Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs)
  • Support management of individual case safety reports for global safety data, data reconciliation activities
  • Provides responses to unsolicited requests for medical information, often in direct collaboration with Medical Information Services personnel, Reconcile data listings between clinical/safety database(s) Safety Data Review (SDR) team
  • Ensure any expedited safety reports are notified to applicable RA, Ethics Committees and Principal Investigators within regulatory timelines and Responsible for timely submission of expedited ICSR reports to Ethics Committees and Investigators based on the country requirements
  • Review compliance of expedited safety reporting on assigned projects and escalate problems or issues to PVG Manager
  • Provide training, mentoring and work direction to more junior level staff, and quality review of data, including SAE and AE reports and Medidata, RAVE, and other clinical databases, other data review tools for therapeutic areas
  • Responsible for expedited reporting requirements dictated by major regulatory authorities
  • Compliance with domestic and international adverse event reporting requirements for all investigational products in global development programs, product-specific surveillance plans, performs signal detection activities, as well as effective CAPA development and management
  • Effectively communicate with team members, client contacts and adverse event reporters.
  • Continuously updated knowledge of industry best practices and emerging trends in occupational safety, applying insights gained to enhance the organization''s safety programs.
  • Collaborated with management to develop strategic safety plans, achieving a more secure working environment.
  • Conducted safety training and education to employees to increase awareness of safety hazards and empower employees to work safely.
  • Devised and monitored safety performance metrics to assess and improve safety performance.
  • Monitored performance metrics related to workplace accidents and near misses, using data-driven insights to inform ongoing improvements in safety measures implemented across the company.
  • Communicated safety performance and progress to management and employees to provide up to date information.
  • Responded to any emergencies as instructed and with utmost efficiency.
  • Conducted regular safety inspections and audits to identify potential hazards and prevent accidents and injuries.
  • Identified accident causes and optimal prevention strategies by conducting thorough investigations and analyses.
  • Collaborated with other departments to integrate safety in all aspects of organization.
  • Recognized, documented, and advised on removal of hazards.
  • Educated employees on hazardous waste management, emergency response and safe work practices.
  • Monitored workplace activities to determine compliance with safety regulations and standards.
  • Developed comprehensive safety training programs for employees, resulting in increased awareness and safer work practices.
  • Investigated accidents and incidents to determine root causes and develop corrective actions to address underlying issues.
  • Researched and devised new safety initiatives and strategies to improve safety performance.
  • Assessed value of safety programs to apply modifications and improvements and achieve targeted goals.
  • Reduced accident rates by implementing effective safety policies and procedures.
  • Streamlined processes for hazard identification and response, increasing efficiency in addressing potential concerns.
  • Implemented targeted interventions for high-risk activities or areas within the workplace, successfully reducing incidents related to these factors.
  • Inspected facilities for adherence to fire, hazard, and safety guidelines.
  • Provided guidance and resources to employees to maintain safety procedures and enhance protection.
  • Conducted safety audits and inspections to identify workplace hazards and deficiencies.
  • Ensured compliance with OSHA regulations by maintaining accurate records and documentation of safety measures taken.
  • Performed safety analyses to evaluate potential risks and develop risk mitigation strategies.
  • Developed emergency response plans tailored to specific worksite needs, ensuring preparedness in times of crisis.
  • Provided new-employee health and safety orientations and developed materials for presentations.
  • Inspected worksites, practices, and gear for compliance with established safety standards.
  • Provided expert advice on risk mitigation strategies, enhancing the company''s ability to manage unforeseen events effectively.
  • Led cross-functional teams to address complex safety issues, ultimately reducing risks and improving overall workplace security.
  • Reviewed and analyzed safety data and statistics to identify trends and areas requiring improvement.
  • Assessed equipment functionality regularly to ensure proper maintenance schedules were followed, minimizing equipment-related hazards within the workplace environment.
  • Liaised with management and employees enable smooth communication regarding safety procedures.
  • Delivered regular safety presentations to staff members at all levels, promoting consistent understanding of best practices across the organization.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Cultivated interpersonal skills by building positive relationships with others.
  • Paid attention to detail while completing assignments.
  • Excellent communication skills, both verbal and written.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Demonstrated leadership skills in managing projects from concept to completion.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Developed and maintained courteous and effective working relationships.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Skilled at working independently and collaboratively in a team environment.
  • Strengthened communication skills through regular interactions with others.
  • Worked effectively in fast-paced environments.
  • Gained strong leadership skills by managing projects from start to finish.

Operation Specialist

IQVIA
04.2021 - 10.2021
  • Review, assess and process safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties, following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members and Safety Data Review (SDR) team
  • Process Safety data for an Emergency Use Authorization (EUA) investigational product vaccine, Infections and Infectious Diseases, medical device and Obstetrics/Gynecology, Pediatrics/Neonatology according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
  • Coding AE and Products, writing narratives, Literature related activities as per internal/project timelines
  • Ensure compliance to all project related processes and activities
  • Creating, maintaining and tracking cases as applicable to project plan
  • Liaise with different functional team members, e.g
  • Project management, clinical, data management, health care professionals e.g
  • Investigators, medical monitors, site coordinators and designees to address project related issues and elevate signal detection findings
  • May liaise with client in relation to details on day-to-day case processing activities
  • Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes
  • Lead/Support department Initiatives.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Collaborated with various departments to develop integrated solutions addressing organizational challenges.
  • Improved operational efficiency by streamlining processes and implementing new workflow strategies.
  • Identified company objectives by analyzing feedback, observing consumers and collecting surveys.
  • Generated reports detailing findings and recommendations.
  • Conducted regular audits of operational procedures, recommending adjustments as needed for optimal efficiency.
  • Evaluated potential risks associated with new projects or ventures, informing decision-making processes accordingly.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
  • Observed packing operations to verify conformance to specifications.
  • Frequently inspected production area to verify proper equipment operation.
  • Educated staff on organizational mission and goals to help employees achieve success.
  • Oversaw inventory management, reducing stock discrepancies and optimizing warehouse space usage.
  • Assisted in the development of long-term strategic goals, aligning operations with company objectives.
  • Optimized customer experience by delivering superior services and effectively troubleshooting issues.
  • Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
  • Created and managed project plans, timelines and budgets.
  • Analyzed data trends to identify opportunities for improvement in operational performance metrics.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Implemented process improvements that increased overall customer satisfaction rates.
  • Coordinated cross-functional teams for successful project execution and timely delivery of services.
  • Assisted various departments with change by communicating new improvement plans and expectations.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Maintained database systems to track and analyze operational data.
  • Reduced costs for the organization by identifying areas of waste and implementing cost-saving measures.
  • Tracked and analyzed reports to determine needed improvements.
  • Motivated and trained employees to maximize team productivity.
  • Devised and implemented processes and procedures to streamline operations.
  • Supported business continuity planning efforts by developing contingency plans and emergency response protocols.
  • Collected, arranged, and input information into database system.
  • Used [Software] to model data and forecast trends.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Facilitated change management initiatives, guiding teams through periods of transition while maintaining morale and productivity levels.
  • Monitored key performance indicators, taking corrective actions when necessary to achieve targets.
  • Managed vendor relationships to ensure high-quality products and services at competitive prices.
  • Optimized resource allocation, ensuring projects were completed on time and within budget.
  • Ensured compliance with industry regulations, minimizing risk exposure for the organization.
  • Developed comprehensive operation plans to support organizational growth and expansion initiatives.
  • Gathered, organized and input information into digital database.
  • Provided training and mentorship to junior staff members, contributing to overall team success.
  • Leveraged technology solutions to automate repetitive tasks, allowing staff members to focus on higher-value activities.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Gained strong leadership skills by managing projects from start to finish.
  • Worked well in a team setting, providing support and guidance.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.
  • Self-motivated, with a strong sense of personal responsibility.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Delivered services to customer locations within specific timeframes.
  • Exercised leadership capabilities by successfully motivating and inspiring others.
  • Demonstrated leadership skills in managing projects from concept to completion.
  • Organized and detail-oriented with a strong work ethic.
  • Paid attention to detail while completing assignments.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Identified issues, analyzed information and provided solutions to problems.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Strengthened communication skills through regular interactions with others.
  • Worked effectively in fast-paced environments.

Safety Data Associate

United BioSource Corporation Blue Bell PA
08.2020 - 04.2021
  • Triaged and registered incoming Adverse Event Reports to determine seriousness for prioritization of daily workflow
  • Performed duplicate and database searches as necessary
  • Worked on literature cases, solicited cases, individual patient cases, spontaneous cases, pregnancy cases, literature cases
  • Performed comprehensive narrative writing and case data entry according to standard operating procedures
  • Attends UBC PV Department meetings
  • Participates in project specific teleconferences/meetings
  • Oversees medical information (MI) for marketed drug products, including responding to product inquiries, processing product complaints, and reporting adverse events and medical device report submission to RA
  • Performed Medical coding using MedDRA and WhoDD in accordance with ICH GCP guidelines
  • Performed labeling, listing for of medical device, endocrine and metabolic, cardiology respiratory neurology and, hematology cases
  • Processed and conducted quality assurance of Clinical Trial and Post marketing Adverse Event reports.
  • Delivered energetic responses to customers in-store and by telephone, going above and beyond to serve needs.
  • Conducted comprehensive market research to identify emerging trends and opportunities for growth within the industry.
  • Streamlined inventory management processes, reducing waste and ensuring optimal stock levels were maintained.
  • Opened, shelved and merchandised new products in visually appealing and organized displays for optimal sales promotions.
  • Developed and implemented strategies to increase customer satisfaction and engagement.
  • Oversaw budget planning and allocation activities, optimizing financial resources to support organizational objectives efficiently.
  • Developed strong client relationships through timely and thorough follow-up on inquiries and concerns.
  • Contributed to risk mitigation efforts through careful analysis of potential threats to operations or profitability, recommending appropriate action plans when necessary.
  • Exceeded sales targets consistently by employing strategic selling techniques and building long-lasting relationships with clients.
  • Spearheaded process improvement initiatives that increased operational efficiency while maintaining high-quality output standards.
  • Recommended complementary purchases to customers, increasing revenue.
  • Monitored customers for signs of security concerns and escalated issues to management.
  • Created promotional materials to advertise products and services.
  • Used in-store system to locate inventory and place special orders for customers.
  • Implemented data-driven decision-making strategies, improving overall business performance.
  • Stocked merchandise, clearly labeling items, and arranging according to size or color.
  • Identified customer needs and wants to enhance customer experiences and boost sales.
  • Maintained up-to-date knowledge of store sales, payment policies and security standards.
  • Played an integral role in launching successful projects by coordinating tasks among team members while adhering closely to established timelines and budgets.
  • Listened to customer needs and desires to identify and recommend optimal products.
  • Collaborated cross-functionally to develop new products, leading to an expanded product portfolio for the company.
  • Assisted in recruiting top talent for various positions within the company, contributing to a high-performing workforce capable of meeting business goals effectively.
  • Provided exceptional services and pleasant shopping experiences to retail customers.
  • Created solutions for customers to satisfy specific needs, quality and budget.
  • Led training sessions for new employees to ensure smooth integration into the company culture and workflow.
  • Prioritized tasks to meet tight deadlines, pitching in to assist others with project duties.
  • Developed comprehensive marketing campaigns that effectively reached target audiences, driving brand awareness and increasing revenues.
  • Prioritized helping customers over completing other routine tasks in store.
  • Created inviting environment for customers by maintaining store organization and cleanliness.
  • Optimized departmental processes with the implementation of innovative strategies, resulting in improved efficiency and reduced costs.
  • Established strong relationships with key stakeholders, facilitating effective communication across departments and teams.
  • Enhanced team productivity by streamlining communication and implementing efficient project management tools.
  • Conducted product demonstrations to highlight features and redirect objections to positive aspects.
  • Maintained relationships with customers to maximize sales opportunities.
  • Managed a diverse team of professionals, fostering an inclusive work environment that encouraged collaboration and innovation.
  • Provided product price information to customers.
  • Developed strong rapport with customers and created positive impression of business.
  • Increased customer satisfaction by resolving complex issues and providing exceptional service at all times.
  • Monitored customer service metrics and performance indicators to identify areas of opportunity.
  • Managed efficient cash register operations.
  • Analyzed customer data to identify trends and anticipate customer needs.
  • Volunteered for extra shifts during holidays and other busy periods to alleviate staffing shortages.
  • Greeted customers and offered assistance for increased customer satisfaction.
  • Answered customer questions about products and services, helped locate merchandise, and promoted key items.
  • Wrapped, boxed and weighed bakery department products.
  • Utilized customer feedback to improve product offerings.
  • Championed a culture of continuous learning, fostering professional development opportunities for staff members to enhance their skills and knowledge.
  • Engaged in friendly conversation with customer to better uncover individual needs.
  • Trained and mentored junior staff on customer service strategies and techniques.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Developed and maintained courteous and effective working relationships.
  • Demonstrated creativity and resourcefulness through the development of innovative solutions.
  • Cultivated interpersonal skills by building positive relationships with others.
  • Proven ability to learn quickly and adapt to new situations.
  • Paid attention to detail while completing assignments.
  • Gained extensive knowledge in data entry, analysis and reporting.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Passionate about learning and committed to continual improvement.
  • Applied effective time management techniques to meet tight deadlines.
  • Worked well in a team setting, providing support and guidance.
  • Skilled at working independently and collaboratively in a team environment.
  • Resolved problems, improved operations and provided exceptional service.
  • Identified issues, analyzed information and provided solutions to problems.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Gained strong leadership skills by managing projects from start to finish.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Strengthened communication skills through regular interactions with others.

Pharmacovigilance Consultant

Sollers
01.2018 - 07.2020
  • Perform Safety Data entry in the database, Coding relevant Medical Terminology, Writing Narratives for Med Watch (FDA 3500A) and CIOMS forms for domestic and international cases, Generating queries pertinent to the case, Evaluation (QC Check)
  • Maintained SOPs and Good Clinical Practice in compliance with ICH guidelines
  • Participate in cross-functional Medical Surveillance Teams (MSTs) and assigned teams, such as Safety Data Review (SDR) Teams, and participate in related PV and product-development team(s)
  • Appropriately elevate issues impacting key activities, milestones, documents to the MST team
  • Involved in Phases (I-IV) of the Clinical Trials in different Therapeutics areas - cardio-vascular, musculoskeletal, nephrology, neurology, ophthalmology, dermatology, devices, gastroenterology, gene therapy and oncology trials, safety data analysis
  • Periodic review of pertinent safety-related literature, analysis of pre-determined core signal data
  • Provides advice and summaries, evaluations and conclusions of safety data reviewed
  • Collaborate with cross-functional teams, including clinical operation, to ensure accurate safety data reporting
  • Scheduled and led team study meetings; reported findings to Lead CRA
  • Collaborate within and across client's functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
  • Optimized customer experience by delivering superior services and effectively troubleshooting issues.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Delivered high-quality presentations to stakeholders, effectively communicating project objectives and results.
  • Organized and analyzed primary and secondary research to understand industry, market and company trends.
  • Analyzed data sets to identify trends and opportunities for process improvements within client organizations.
  • Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
  • Collected, arranged, and input information into database system.
  • Developed innovative strategies for clients, resulting in increased revenue and business growth.
  • Gathered, organized and input information into digital database.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Established trusted partnerships with key industry influencers, expanding the company''s network of resources and contacts.
  • Collaborated with teams to define, strategize, and implement marketing and web strategies.
  • Created and managed project plans, timelines and budgets.
  • Implemented practices and procedures to reduce expenditures and increase savings.
  • Managed client relationships through regular check-ins and updates on project progress.
  • Frequently inspected production area to verify proper equipment operation.
  • Onboarded and managed new client accounts to boost retention rates.
  • Maintained database systems to track and analyze operational data.
  • Advised clients on change management strategies to ensure smooth transitions during periods of organizational transformation.
  • Facilitated workshops with stakeholder groups to gain consensus on priorities and approaches for tackling identified issues or opportunities.
  • Automated system e-commerce features to improve client sales.
  • Collaborated with cross-functional teams to successfully deliver comprehensive solutions for clients.
  • Renegotiated outsourcing contracts to save considerable costs.
  • Enhanced communication among team members, fostering a collaborative and supportive work environment.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Identified areas of improvement for clients'' operations, implementing targeted solutions to increase productivity.
  • Prepared presentations to explain revisions, enhancements and process improvements of organization's systems and programs.
  • Evaluated client needs and expectations, establishing clear goals for each consulting engagement.
  • Improved client satisfaction by effectively managing multiple projects and consistently meeting deadlines.
  • Managed multiple deadlines across several businesses to meet dynamic needs of multiple clients.
  • Supported clients with business analysis, documentation, and data modeling.
  • Conducted thorough market research and analysis, providing valuable insights for client decision making.
  • Designed tailored training programs for employees at various levels within the organization, boosting overall skillsets.
  • Liaised with customers, management, and sales team to better understand customer needs and recommend appropriate solutions.
  • Integrated technology and business operations to identify targeted solutions to customer issues.
  • Delivered outstanding service to clients to maintain and extend relationship for future business opportunities.
  • Devised and implemented processes and procedures to streamline operations.
  • Provided ongoing support to clients post-implementation, ensuring long-term success of implemented solutions.
  • Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
  • Aligned closely with business owners and employees to gather information and gain operational insight.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Educated staff on organizational mission and goals to help employees achieve success.
  • Generated reports detailing findings and recommendations.
  • Implemented best practices to optimize clients'' organizational performance, leading to improved operational efficiency.
  • Mentored junior consultants, fostering professional growth and building strong team dynamics.
  • Negotiated contracts on behalf of clients, securing favorable terms that contributed to their overall success.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Streamlined internal processes to enhance team efficiency and improve overall project outcomes.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Observed packing operations to verify conformance to specifications.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Gained strong leadership skills by managing projects from start to finish.
  • Skilled at working independently and collaboratively in a team environment.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.
  • Strengthened communication skills through regular interactions with others.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Organized and detail-oriented with a strong work ethic.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Excellent communication skills, both verbal and written.
  • Applied effective time management techniques to meet tight deadlines.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Created monthly forecast templates and resource management allocations for approved projects.
  • Provided professional services and support in a dynamic work environment.
  • Developed strong organizational and communication skills through coursework and volunteer activities.
  • Proven ability to learn quickly and adapt to new situations.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Exercised leadership capabilities by successfully motivating and inspiring others.
  • Gained extensive knowledge in data entry, analysis and reporting.
  • Developed and maintained courteous and effective working relationships.
  • Demonstrated strong organizational and time management skills while managing multiple projects.

Clinical SAS Consultant & Safety Associate

Heptronik Corporation
01.2014 - 11.2017
  • Processed and conducted quality assurance of Clinical Trial and Post marketing Adverse Event reports
  • Triaged and registered incoming Adverse Event Reports to determine seriousness for prioritization of daily workflow
  • Performed duplicate and database searches as necessary
  • Worked on literature cases, solicited cases, individual patient use cases, spontaneous cases, pregnancy cases, literature cases for clinical trial in cardiology, oncology, neuroscience, respiratory, musculoskeletal
  • Identified and worked on potential signal detection cases
  • Performed comprehensive narrative writing and case data entry according to standard operating procedures
  • Liaise with the Medical reviewing team for any coding relevant queries
  • Performed Medical coding using MedDRA and WhoDD in accordance with ICH GCP guidelines
  • Performed labeling, listing.
  • Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
  • Collaborated with teams to define, strategize, and implement marketing and web strategies.
  • Integrated technology and business operations to identify targeted solutions to customer issues.
  • Improved client satisfaction by effectively managing multiple projects and consistently meeting deadlines.
  • Observed packing operations to verify conformance to specifications.
  • Onboarded and managed new client accounts to boost retention rates.
  • Optimized customer experience by delivering superior services and effectively troubleshooting issues.
  • Developed effective improvement plans in alignment with goals and specifications.
  • Advised clients on change management strategies to ensure smooth transitions during periods of organizational transformation.
  • Assisted clients in navigating complex industry challenges, offering expert guidance and strategic recommendations.
  • Automated system e-commerce features to improve client sales.
  • Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
  • Evaluated client needs and expectations, establishing clear goals for each consulting engagement.
  • Enhanced communication among team members, fostering a collaborative and supportive work environment.
  • Generated reports detailing findings and recommendations.
  • Collected, arranged, and input information into database system.
  • Delivered outstanding service to clients to maintain and extend relationship for future business opportunities.
  • Analyzed data sets to identify trends and opportunities for process improvements within client organizations.
  • Supported clients with business analysis, documentation, and data modeling.
  • Prepared presentations to explain revisions, enhancements and process improvements of organization's systems and programs.
  • Established trusted partnerships with key industry influencers, expanding the company''s network of resources and contacts.
  • Maintained database systems to track and analyze operational data.
  • Organized and analyzed primary and secondary research to understand industry, market and company trends.
  • Facilitated workshops with stakeholder groups to gain consensus on priorities and approaches for tackling identified issues or opportunities.
  • Created and developed detailed work plans to meet business priorities and deadlines.
  • Educated staff on organizational mission and goals to help employees achieve success.
  • Negotiated contracts on behalf of clients, securing favorable terms that contributed to their overall success.
  • Aligned closely with business owners and employees to gather information and gain operational insight.
  • Created monthly forecast templates and resource management allocations for approved projects.
  • Delivered high-quality presentations to stakeholders, effectively communicating project objectives and results.
  • Collaborated with cross-functional teams to successfully deliver comprehensive solutions for clients.
  • Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
  • Gathered, organized and input information into digital database.
  • Developed innovative strategies for clients, resulting in increased revenue and business growth.
  • Implemented practices and procedures to reduce expenditures and increase savings.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Implemented best practices to optimize clients'' organizational performance, leading to improved operational efficiency.
  • Created and managed project plans, timelines and budgets.
  • Conducted regular reviews of operations and identified areas for improvement.
  • Renegotiated outsourcing contracts to save considerable costs.
  • Streamlined internal processes to enhance team efficiency and improve overall project outcomes.
  • Evaluated staff performance and provided coaching to address inefficiencies.
  • Frequently inspected production area to verify proper equipment operation.
  • Liaised with customers, management, and sales team to better understand customer needs and recommend appropriate solutions.
  • Helped meet changing demands by recommending improvements to business systems or procedures.
  • Provided ongoing support to clients post-implementation, ensuring long-term success of implemented solutions.
  • Devised and implemented processes and procedures to streamline operations.
  • Managed client relationships through regular check-ins and updates on project progress.
  • Managed multiple deadlines across several businesses to meet dynamic needs of multiple clients.
  • Identified areas of improvement for clients'' operations, implementing targeted solutions to increase productivity.
  • Applied effective time management techniques to meet tight deadlines.
  • Organized and detail-oriented with a strong work ethic.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Delivered services to customer locations within specific timeframes.
  • Developed strong organizational and communication skills through coursework and volunteer activities.
  • Developed and maintained courteous and effective working relationships.
  • Excellent communication skills, both verbal and written.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Developed strong communication and organizational skills through working on group projects.
  • Participated in team projects, demonstrating an ability to work collaboratively and effectively.
  • Worked well in a team setting, providing support and guidance.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Skilled at working independently and collaboratively in a team environment.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Worked effectively in fast-paced environments.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Exercised leadership capabilities by successfully motivating and inspiring others.
  • Demonstrated creativity and resourcefulness through the development of innovative solutions.
  • Streamlined incident reporting process to ensure timely resolution and corrective actions.
  • Continuously monitored and updated safety policies and procedures to ensure alignment with industry best practices and regulatory requirements.
  • Collaborated with management to develop policies for a safe work environment, resulting in fewer incidents.
  • Investigated accidents and incidents to determine root causes and develop corrective actions to address underlying issues.
  • Investigated incidents, determining root causes and implementing corrective actions.
  • Assisted in the development of company-wide safety programs, leading to improved overall safety performance.
  • Increased employee awareness of safety procedures through regular communications, posters, and presentations.
  • Conducted risk assessments for various projects, ensuring all safety measures were in place before commencement.
  • Developed effective working relationships with employees at all levels within the organization, fostering a culture of safety consciousness across teams.
  • Developed and implemented safety policies and procedures to establish clear guidelines for safe work practices and comply with regulations.
  • Researched and devised new safety initiatives and strategies to improve safety performance.
  • Provided new-employee health and safety orientations and developed materials for presentations.
  • Maintained accurate records of all workplace incidents, allowing for better tracking of trends and improvements over time.
  • Reduced accident rates by implementing safety protocols and providing training to employees.
  • Developed and implemented safety policies and procedures to promote workplace safety.
  • Analyzed accident data to identify trends and implemented preventive measures accordingly.
  • Communicated safety performance and progress to management and employees to provide up to date information.
  • Investigated accidents thoroughly, identifying root causes and implementing corrective actions to prevent recurrence.
  • Conducted regular safety inspections and audits to identify potential hazards and prevent accidents and injuries.
  • Educated employees on hazardous waste management, emergency response and safe work practices.
  • Enhanced emergency response capabilities by organizing drills and updating evacuation plans.
  • Devised and monitored safety performance metrics to assess and improve safety performance.
  • Reviewed and analyzed safety data and statistics to identify trends and areas requiring improvement.
  • Inspected facilities for adherence to fire, hazard, and safety guidelines.
  • Responded to any emergencies as instructed and with utmost efficiency.
  • Provided support during audits by gathering relevant documentation, demonstrating the organization''s commitment to safety standards.
  • Administered first aid treatment when required while maintaining proper documentation of each incident.
  • Identified accident causes and optimal prevention strategies by conducting thorough investigations and analyses.
  • Coordinated with regulatory agencies to ensure compliance with local, state, and federal safety regulations.
  • Conducted safety audits and inspections to identify workplace hazards and deficiencies.
  • Performed safety analyses to evaluate potential risks and develop risk mitigation strategies.
  • Organized safety training sessions on a variety of topics such as ergonomics, chemical handling, fire safety, and electrical hazards.
  • Collaborated with other departments to integrate safety in all aspects of organization.
  • Liaised with management and employees enable smooth communication regarding safety procedures.
  • Improved workplace safety by conducting regular inspections and identifying potential hazards.
  • Conducted safety training and education to employees to increase awareness of safety hazards and empower employees to work safely.
  • Monitored workplace activities to determine compliance with safety regulations and standards.
  • Assessed value of safety programs to apply modifications and improvements and achieve targeted goals.
  • Coordinated emergency response plans and drills to increase preparedness and address issues promptly.
  • Inspected worksites, practices, and gear for compliance with established safety standards.
  • Led safety committee meetings to discuss ongoing concerns and develop action plans for improvement.
  • Provided guidance and resources to employees to maintain safety procedures and enhance protection.
  • Resolved problems, improved operations and provided exceptional service.
  • Identified issues, analyzed information and provided solutions to problems.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.
  • Gained extensive knowledge in data entry, analysis and reporting.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Provided professional services and support in a dynamic work environment.
  • Cultivated interpersonal skills by building positive relationships with others.
  • Proven ability to learn quickly and adapt to new situations.
  • Self-motivated, with a strong sense of personal responsibility.
  • Managed time efficiently in order to complete all tasks within deadlines.

Caring for Family

Caring For Family
01.2011 - 01.2014
  • Stayed at home with young children for 3 years
  • Demonstrated strong organizational and time management skills while managing multiple task.

Dental Surgeon /Lecturer /Clinical Coordinator

Government Dental College and Hospital – Mumbai
01.1990 - 01.2011
  • Triaged patients in different clinical settings and monitored them closely for diagnosis and treatment efficacies
  • Work with clinical teams in the diagnosis, management, and treatment of various acute and chronic disease states including traumatic teeth injuries, child abuse & neglect, developmental deformities especially with pediatric patients
  • Train and prepare dental graduates for Case history, diagnosis and treatment in clinical set-up, managed patients for dental implants, periodontal surgeries, dental prothesis, and oral surgeries with operative and preventive dentistry complying with licensing requirements and quality check
  • Oversaw all equipment, inventory and ordering of reagents and supplies, developed and implemented laboratory SOPs
  • Coordinate with multidisciplinary research teams to execute clinical trials for Cardiology/Vascular Diseases, Dental and Oral Health, Infections and Infectious Diseases, Immunology and Hepatology, cardiology research, including patient enrollment, qualification visits, and site initiation visits
  • Ensured proper tracking and organization of patient visits, Follow Up drug supply, and adverse events using electronic data capture (EDC) and clinical trial management systems (CTMS).
  • Managed busy surgical office with 25 providers, 10 staff and 255weekly patients.
  • Supervised and managed daily activities of clinical team consisting of 23 dental surgeons nurses, and support staff.
  • Educated patients on proper home care routines aimed at reducing plaque buildup leading to gum disease and tooth decay over time.
  • Performed root canal procedures to treat nerve and dental pulp issues and prevent further damage to teeth and gums.
  • Administered general and local anesthetics.
  • Performed complex dental surgeries, ensuring optimal outcomes for patients.
  • Maintained detailed patient records, tracking progress and adjusting treatments as needed.
  • Spearheaded initiatives to modernize equipment within the practice, improving overall quality of care for patients while increasing productivity levels among staff members.
  • Contributed to the practice''s growth by participating in community outreach events and promoting oral health education.
  • Investigated, diagnosed and treated maxillofacial issues with with gentle care and medically compromised patients.
  • Treated infections of oral cavity, salivary glands, jaw, face and neck.
  • Improved patient satisfaction by providing thorough consultations and personalized treatment plans.
  • Investigated, diagnosed and treated maxillofacial issues with with gentle care and medically compromised patients.
  • Managed dental emergencies efficiently, minimizing pain and discomfort while stabilizing the affected area until further treatment could be provided.
  • Alleviated infections with debriding and surgical procedures.
  • Completed bone grafts, surgical root canals and other procedures to tackle advanced concerns.
  • Closely monitored patient comfort during treatments, adjusting tools and medications to uphold best-in-class comfort standards.
  • Conducted research on defects, diseases, and disorders affecting oral and facial regions.
  • Continually updated knowledge of industry advancements through attendance at conferences and professional development courses.
  • Diagnosed conditions of hard and soft tissues of teeth, jaws and supporting structures and explained corrective measures to patients.
  • Provided instruction on diet, brushing, flossing, and other aspects of oral health to patients.
  • Administered anesthetics and sedatives to control patients' pain and reduce stress for anxious patients during procedures.
  • Assisted colleagues in more specialized procedures such as root canal therapies or orthodontic treatments when necessary to ensure optimal results for patients.
  • Reviewed patient health history and performed checkups to assess current issues.
  • Enhanced patient comfort with the use of advanced anesthetic techniques and pain management strategies.
  • Created individualized treatment plans to maintain or restore oral health of patients.
  • Performed surgical procedures to extract impacted or damaged teeth, place dental implants and remove tumors and other abnormal growths.
  • Performed • Performed periodontal surgery, cleft lip/palate ,oral deformity impactions, broken teeth surgeries to resolve or reduce concerns.
  • Administered anesthetics before surgeries and closely monitored vitals to administer more and maintain patient comfort.
  • Consulted with patients and analyzed patient data to determine patient needs and treatment goals.
  • Implemented infection control protocols, maintaining a safe and clean environment for both staff members and patients.
  • Diagnosed oral diseases accurately through careful examination of radiographs, photographs, models, or impressions based on clinical findings.
  • Provided emergency surgeries for patients with broken teeth or facial bones, prioritizing both functionality and aesthetics during treatments.
  • Passionate about learning and committed to continual improvement.
  • Managed large class sizes effectively, maintaining an orderly learning environment conducive to student success.
  • Created and designed quizzes, tests and projects to assess student knowledge.
  • Promoted collaboration among students through group projects and presentations, fostering teamwork and communication skills.
  • Designed and implemented various educational activities and programs to meet student needs.
  • Devised and implemented clinical protocols to ensure high-quality patient care.
  • Worked closely with clinic administrators to maintain a safe, clean and well-organized environment in which patients could receive care.

Education

Dental Council of India
India

Skills

  • Oracle Argus Drug Safety database (Version 84), ARISG and MedDRA (Version 260)
  • ICH E6 (R2), GVP Guidelines and GCP regulations
  • Experience in Corrective and Preventative Action (CAPA) in analytical roles
  • Knowledge of 21 Code of Federal Regulation parts CRF 11, 50, 54, 56, 312
  • Serious Adverse Event (SAE) reporting and Individual Case Safety Reporting (ICSR)
  • Knowledge and understanding for Risk Evaluation and Mitigation Strategy (REMS)
  • Proficient in MS Office, Veeva Vault, Tableau and SAS certification (Version 140)

Timeline

Senior Safety Specialist

Thermo Fisher Scientific- CRG
11.2021 - Current

Operation Specialist

IQVIA
04.2021 - 10.2021

Safety Data Associate

United BioSource Corporation Blue Bell PA
08.2020 - 04.2021

Pharmacovigilance Consultant

Sollers
01.2018 - 07.2020

Clinical SAS Consultant & Safety Associate

Heptronik Corporation
01.2014 - 11.2017

Caring for Family

Caring For Family
01.2011 - 01.2014

Dental Surgeon /Lecturer /Clinical Coordinator

Government Dental College and Hospital – Mumbai
01.1990 - 01.2011

Dental Council of India

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