Shekar Naidu Dwarapudi
Jersey City,NJ
Summary
Seeking a challenging career in an organization that promotes growth, stability and opportunity for advancement in the field of Compliance Analyst. Experienced, compassionate and empathetic Healthcare Professional adept at evaluating patient conditions, medical records, and treatment objectives. Capable of administrative operations, assessing, testing, and implementing rehabilitation goals based on individual’s ability and goals. Innate ability to establish rapport quickly, build trust, and interact with individuals of diverse backgrounds.
Reliable Quality Control Specialist with abilities in blueprint interpretation, operations monitoring and quality control inspections. Outstanding communication, active listening, and organizational talents. Physically fit and adaptable with the capability to work in various work environments.
Overview
12
12
years of professional experience
Work History
Pharmacovigilance Associate
ProCareer
08.2021 - 06.2024
- Assessed labelling of serious adverse events originating from spontaneous, clinical sources with reference to IB, CCDS, SmPC, and USPI.
- Ensured Confidential coding
- Hands-on expertise in end-to-end Case Processing in Pharmacovigilance database ARISg.
- Assisted in upgrading or downgrading of case, where applicable based on the medical assessment and seriousness criteria.
- Quality Check of Confidential which included review of source documents and ensuring that the case is accurate, correct and complete.
- Maintained a good working knowledge of the AE safety profile of assigned drugs, reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations.
- Assessed and distributed pharmaceutical product adverse event documents.
- Monitored deliverables for quality and adherence to regulatory reporting timelines.
- Oversaw adverse events case reporting and conducted follow-up.
- Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
- Reviewed, compiled and analyzed data for safety database management.
- Evaluated safety profiles, wrote signal detection reports and monitored document filing and archiving.
- Liaised between quality control and other departments and contractors, providing project updates and consultation.
Drug Safety Associate
ProCareer
03.2019 - 02.2020
- Maintained an awareness of global regulatory reporting obligations and organized workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
- Drafted individual case summary reports and wrote concise case specific narratives as per company/product conventions.
- Processed literature cases which included cases from medical journals abstracts, poster presentation, literature summary cases and full literature articles.
- Sound knowledge of 21 CFR Parts 11/312/314, MHRA best practices and ICH recommendations.
- Interacted with team manager to discuss ongoing projects and maintain workflow and timelines.
- Worked in different therapeutics areas like Parkinson's disease, Alzheimer's disease, Breast cancer, Prostate cancer.
- Experienced in French Imputability method of causality assessment.
- Knowledge of aggregate reports including PSURs/PBRERs, PADER, and Clinical trials protocol, Informed Consent, Investigator Brochure (IB).
- Requested and provided follow-ups on adverse events by preparing, sending out and tracking queries.
- Experienced in handling the ERP (Enterprise Resource Planning) system.
- As mentor, trained new team members on safety data processing and project related activities.
- Communicated with internal or external contacts to resolve issues related to case processing.
- Navigated intricacies of drug safety databases to process adverse event reports.
Intern Compliance & Validation Analyst
Srivin Infosystems Inc
04.2018 - 10.2018
- Prepare a NCR and construction-related document that addresses specification deviation or work that fails to meet quality standards.
- Prepare a CAPA process, including issuing non-conformances (NCRs), deviations, and complaints.
- Develop and maintain quality assurance standards in accordance with legal and regulatory standards.
- Monitor and review operations to ensure compliance with applicable laws and regulations.
- Create and implement compliance processes and procedures.
- Conduct internal audits and report findings.
- Investigated and resolved compliance issues in a timely manner.
- Monitored changes in applicable laws and regulations and assessed their impact on the organization.
- Analyzed problems and worked with teams to develop solutions.
- Sorted and organized files, spreadsheets, and reports.
- Explored new technologies and approaches to streamline processes.
- Prepared project presentations and reports to assist senior staff.
- Evaluated function, performance and design compliance of every product against design standards and customer needs.
- Conducted regular reviews of operations and identified areas for improvement.
- Gathered data on integration issues and vulnerabilities, reported findings and recommended improvements.
- Monitored resolution of bugs, tested fixes, and helped developers tackle ongoing problems by providing QA perspective.
- Built automated test scripts to handle repetitive software testing work.
- Operated under Agile and Scrum frameworks to complete releases and well-organized sprints.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Observed packing operations to verify conformance to specifications.
- Evaluated customer needs and feedback to drive product and service improvements.
- Participated in workshops and presentations related to projects to gain knowledge.
- Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
Management & Compliance Analyst (Internship)
BANSI Pharmacy Inc
09.2017 - 04.2018
- Study the work problems and procedures for communication delay, information flow, inventory control and cost analysis.
- Gather information on work problems regarding the operational and communication procedures and analyze the information gathering to consider solutions and alternate methods of problem solving and proceedings.
- Manage to measure performance and report on patient's medical record according to HIPPA standards, utilizing the FDA guidelines.
- Successfully developed paper business reports, memoranda and instructional manuals as documentation of corporate development and prepare work flowcharts and diagrams to specify in detail operation to be performed by personnel.
- Perform quality assessment and review of occurrences (CAPA). Utilize various recording and tracking systems (such as internal databases) to analyze events and determine appropriate resolution with guidance of management. Verify effectiveness of any corrective and preventative actions.
- Reviewed audit and monitoring reports related to consumer and client activities.
- Stayed current with latest changes to applicable regulatory standards and company procedures.
- Developed improvement and corrective action plans to bring operations in line with requirements.
- Prepared documentation and records for upcoming audits and inspections.
- Assisted investigation and risk management teams with fraud investigations and risk identification.
- Assisted with development of compliance objectives and strategies.
- Conducted periodic compliance audits and reviews to identify areas of improvement.
- Supported and trained customers on compliance-related issues.
- Determined licensing eligibility by examining test results and comparing against established structures.
- Evaluated and monitored supplier and partner relationships to support compliance.
- Kept informed regarding pending industry changes, trends or best practices.
- Updated EMR spreadsheets with latest data to enhance strategic planning.
- Investigated locations to confirm license data, conducted background checked and assessed premises for compliance with licensing requirements.
- Directed activities of workers searching records and provided technical guidance as necessary.
- Developed and implemented corrective action plans for non-compliance issues.
- Took notes on field examinations and specific case details, updated databases and produced reports outlining results of investigations.
- Maintained up-to-date knowledge of applicable laws and regulations.
Physical Therapist & Rehab Manager
Ortho- Neuro care Physiotherapy & Rehabilitation Center
02.2013 - 03.2015
- Provided treatments, electrotherapy modalities, and exercise programs based on individual's ability.
- Worked with other professional staff members in the center in evaluating, planning and executing the therapeutic treatment procedures.
- Formulated care of plan for patients.
- Aided patients suffering from various neurological disorders to restore function, lessen pain and disability.
- Delivered home care rehabilitation services with patient satisfaction.
Physical Therapist (Internship)
Krishna Institute of Medical Science Hospital and Research Center
07.2012 - 01.2013
- Underwent rotational internship in all the departments Orthopedics unit, Neurology unit Cardiology rehab unit and CT Cardio ICU.
- Underwent hands on practice at pre-operative stage to post-operative conditions in all the three departments.
- Assist Physical Therapist's in rehabilitating patients (In-patient and out-patient departments).
- Managed to evaluate, assess, and formulate exercise safety for patients in the Cardiac Care Unit, Traumatic Intensive Care Unit, Respiratory Care Unit.
Physical Therapist (Internship)
National Institute for the Mentally Handicap(NIMH)
10.2012 - 11.2012
- Community Based Rehabilitation.
- Underwent rotatory internship training on Early intervention Services, Nutritional advice, Behavior modification education, occupational re-education.
Education
Master of Science - Healthcare Administration and Management
Wilmington University
01.2017
Bachelor of Science - Life Science, Physiotherapy
NTR University of Health Sciences
01.2012
Skills
- Clinical trial management
- Experience with cGMP/FDA Regulations
- Quality assurance oversight
- Technical documentation
- ICH guideline knowledge
- Experience in CPT and ICD coding
- Proficient in bio-pharma principles
- Proficient in MS Office 365
- Adverse event monitoring
- Database administration
- Experience with ERP systems
- Experience with Oracle Argus Safety
- ERP/EHA/EMR
- Knowledge of HIPAA regulations
- Compliance Management
- Accurate data entry
- Labeling
Languages
English
Professional Working
Hindi
Full Professional
Telugu
Professional Working
Timeline
Pharmacovigilance Associate
ProCareer
08.2021 - 06.2024
Drug Safety Associate
ProCareer
03.2019 - 02.2020
Intern Compliance & Validation Analyst
Srivin Infosystems Inc
04.2018 - 10.2018
Management & Compliance Analyst (Internship)
BANSI Pharmacy Inc
09.2017 - 04.2018
Physical Therapist & Rehab Manager
Ortho- Neuro care Physiotherapy & Rehabilitation Center
02.2013 - 03.2015
Physical Therapist (Internship)
National Institute for the Mentally Handicap(NIMH)
10.2012 - 11.2012
Physical Therapist (Internship)
Krishna Institute of Medical Science Hospital and Research Center
07.2012 - 01.2013
Master of Science - Healthcare Administration and Management
Wilmington University
Bachelor of Science - Life Science, Physiotherapy
NTR University of Health Sciences
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