Swimming, Gyming, & Marathon Run
MANOJ kumar JENA
Associate Director, Pharamacovigilance Safety Operations
Hyderabad,Telangana
Summary
With over 18 years of experience in the pharmaceutical industry, I have expertise in Pharmacovigilance - Processing & Reporting of Individual Case Safety, Safety Database Customizations & User Acceptance Testing/Validations, Literature Review, Business process excellence and robotic process automations, project management, audit and inspection readiness. As the Associate Director of Pharmacovigilance Safety Operations at Parexel, I lead a team of Healthcare/Life science professionals in ensuring the safety and quality of clinical trials and post marketing programs. Holding an EMBA in International Business from Institute of Management and Technology- Ghaziabad and Certificates in PMP and PMI-ACP from Institute Project Management Institute. Passionate about building First Time Quality and enhance operational efficiency. Additionally, enjoys sharing knowledge and skills through training, mentorship, and thought leadership forums.
Overview
18
18
years of professional experience
Work History
Associate Director, Safety Operations
PAREXEL International
Hyderabad
10.2021 - Current
- Input and oversight of Regional Safety Services processes and procedures, including continuous improvement.
- Supports the regional strategic direction and resource allocations jointly with the regional safety head in India.
- Support market and business development on behalf of the entire Safety Services organization.
- Provide regional input into Safety Services business plan, development, budgets, general and growth strategy, including global expansion.
- Act as technical expert of PV Drug Safety Services for internal and external stakeholders.
- Contribute to overseeing quality and compliance of Safety Services in that region, as well as for regional people, process and technology support of Safety Service objectives.
- Participate in providing high-caliber Safety Service consulting to internal and external stakeholders and clients.
- Input into the alignment of the Regional Safety Services group with the global safety Services organization.
- Responsible for quality and compliance of regional safety Services group input and oversight of regional safety Services processes and procedures, including continuous improvement.
- Provide regional input into Safety Services business plan, development, budgets, general and growth strategy, including global expansion.
- Train and mentor/supervise Regional Safety Services staff and assists in the training of Safety Physicians/Medical Monitors.
- Public representation of the Safety Services organization, including attendance and presentations at international conferences as appropriate.
- Work closely with colleagues in Safety Services Business Operations and regional Safety Services Project Lead (SSPLs) on Safety Services proposals and projects.
- Support regional Medical Monitors as required.
- Provide Safety Services expertise and training to other PAREXEL personnel, as appropriate keeps current with professional and Safety knowledge.
Senior Manager - Pharmacovigilance Operations
Parexel International
05.2019 - 10.2021
- Utilize Business Process Management, Project Management and Client Management expertise for capability assessments leading to identification, organization and establishment of large, complex, cross-functional projects and initiatives directly impacting the operational and financial success of function.
- Ensured retention of talent pool to meet the demands and delivery at par with expectation forecasted by business function.
- Handled internal and external project/ process related conflicts/change management issues, and identify, communicate and manage the project risks.
- Support internal, customer and regulatory audits and inspections.
- Managed directly and provided direction to multiple teams with high regulatory impact and visibility with diligence to implement and sustain consistent, efficient and quality processes to meet timelines and deliverables.
- Formulated procedures and result oriented project planning for insightful data analysis driving the project teams for project execution, providing subject matter expertise in establishing efficient workflows, creating and monitoring of the key performance indicators in operational delivery.
- Supported internal, and external stake holders, regulatory/sponsor audits and inspections.
- Create project plans defining the objective, scope, deliverables and timelines. Handle conflict and change management issues.
- Handled internal and external project/ process related conflicts/change management issues, and identify, communicate and manage the project risks.
- Ensure all activities are in compliance with the SOP, PV legislation and GVP requirement.
- Plan and implement innovative solutions to the issues that are faced by PAREXEL India Safety Services to ensure smooth operational goals.
- Ensured retention of talent pool to meet the demands and delivery at par with expectation forecasted by business function.
- Partnered with Management for Talent acquisition, project initiation, project management, transition management providing subject matter expertise in establishing efficient workflows, creating and monitoring of the key performance indicators in operational delivery and Client Management.
- Ensure career progression and overall development of the direct reports.
- Plan and implement innovative solutions to the issues that are faced by PAREXEL India Safety Services to ensure smooth operational goals.
- Ensure retention of talent to meet the growing demands of the function.
- Manage and lead processing team and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures.
- Responsible for induction training of new associates.
- Monitor workload and allocates resources appropriately.
- Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate. Provide feedback to team members on quality and train team members as appropriate to improve quality.
- Set up yearly objectives and review performances of team ensuring best use of available resources.
- Discuss and set up development plans with/for all team members to further develop individual's skills and potentials.
- Set up the training plans for new hires according to the individual's experience and job role and ensure that training is provided to team as appropriate. Support the training of other departments in clinical safety related procedures/regulatory obligations.
- QC periodic regulatory safety reports before submission to management approval and ensure compliance with required timelines and co-author, together with the Medical Safety Physicians, periodic regulatory safety reports, as appropriate.
- Interact with the Medical Safety Physicians on project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports.
- Represent PAREXEL India Safety Services at internal and external meetings.
- Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports.
- Evaluate and manage resource allocation in different projects.
- Management, support, direction, coordination and planning for any medical and other pharmacovigilance (PV) related activities, including oversight of and contribution to PV consulting projects.
- Strategic input, including providing subject matter expertise in the planning and setup of PV projects, including costing, budgeting, resourcing, workflow and process design and analysis.
- Timely contribution to and strategic input and review of proposals (RFP), and contracts as required.
- Liaison with internal (e.g. business operations, account management, PAREXEL Consulting) and external stakeholders (e.g. clients, and third party vendors).
- Contribute to Medical and PV-Operations resource planning and strategy.
Team Manager - Pharmacovigilance Operations
Parexel International
05.2016 - 04.2019
- In Project Manager (Safety Services project Leader) Role: Maintenance of a project plan.
- Monthly revenue recognition and forecast activities.
- Invoicing according to contract-service and pass-through cost (in cooperation with Project Analyst).
- Monthly control/adjustment of time reported (in TIME).
- Project close out activities WW (in cooperation with Project Analyst).
- First point of contact for the client for all financial related issues (e.g. CIS, reminders).
- Coordination/management of project team.
- Management, support, direction, coordination and planning for any medical and other pharmacovigilance (PV) related activities, including oversight of and contribution to PV consulting projects.
- Strategic input, including providing subject matter expertise in the planning and setup of PV projects, including costing, budgeting, resourcing, workflow and process design and analysis.
- Provide training and mentoring to other, less experienced Drug Safety Staff.
- Timely contribution to and strategic input and review of proposals (RFP), and contracts as required.
- Liaison with internal (e.g. business operations, account management, PAREXEL Consulting) and external stakeholders (e.g. clients, and third-party vendors).
- Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate.
- Contribute to Medical and PV-Operations resource planning and strategy.
- Contribute to the costing of Medical and PV-Operations projects, including the review of and improvement of performance metrics and costing tools.
- Attend and lead client meetings.
- Provide timely input and feedback to process improvement.
- In Operation & People management role: Ensure career progression and overall development of the direct reports.
- Plan and implement innovative solutions to the issues that are faced by PAREXEL India Safety Services to ensure smooth operational goals.
- Ensure retention of talent to meet the growing demands of the function.
- Manage and lead processing team and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures.
- Responsible for induction training of new associates.
- Monitor workload and allocates resources appropriately.
- Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate. Provide feedback to team members on quality and train team members as appropriate to improve quality.
- Set up yearly objectives and review performances of team ensuring best use of available resources.
- Discuss and set up development plans with/for all team members to further develop individual's skills and potentials.
- Set up the training plans for new hires according to the individual's experience and job role and ensure that training is provided to team as appropriate. Support the training of other departments in clinical safety related procedures/regulatory obligations.
- QC periodic regulatory safety reports before submission to management approval and ensure compliance with required timelines and co-author, together with the Medical Safety Physicians, periodic regulatory safety reports, as appropriate.
- Interact with the Medical Safety Physicians on project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports.
- Represent PAREXEL India Safety Services at internal and external meetings.
- Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports.
- Evaluate and manage resource allocation in different projects.
Associate Team Manager - Pharmacovigilance Operations
Parexel International
05.2013 - 04.2016
- Attend and lead client meetings.
- Provide timely input and feedback to process improvement.
- Ensure career progression and overall development of the direct reports.
- Plan and implement innovative solutions to the issues that are faced by PAREXEL India Safety Services to ensure smooth operational goals.
- Ensure retention of talent to meet the growing demands of the function.
- Manage and lead processing team and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures.
- Responsible for induction training of new associates.
- Monitor workload and allocates resources appropriately.
- Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate. Provide feedback to team members on quality and train team members as appropriate to improve quality.
- Set up yearly objectives and review performances of team ensuring best use of available resources.
- Discuss and set up development plans with/for all team members to further develop individual's skills and potentials.
- Set up the training plans for new hires according to the individual's experience and job role and ensure that training is provided to team as appropriate. Support the training of other departments in clinical safety related procedures/regulatory obligations.
- QC periodic regulatory safety reports before submission to management approval and ensure compliance with required timelines and co-author, together with the Medical Safety Physicians, periodic regulatory safety reports, as appropriate.
- Interact with the Medical Safety Physicians on project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports.
- Represent PAREXEL India Safety Services at internal and external meetings.
- Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports.
- Evaluate and manage resource allocation in different projects.
Drug Safety Specialist
Parexel International
02.2011 - 05.2013
- Core Pharmacovigilance responsibilities: Allocation of mentors and training for the new associates in consultation with the senior management in Parexel India Safety Services team.
- Keeping the track of individual performance and quality in the team for the appraisal.
- Lead/Co-Lead cross-functional teams contributing to Safety management plan involving all clinical trial projects in accordance with Parexel business rules, standard operating procedures and global regulatory requirements.
- Update the team members about the change in SOPs and policies of management.
- Keep the track of the individual assigned associates of completion of SOPs.
- Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on the regulatory timeliness and quality.
- Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed.
- Assist the Medical Safety Physicians in monitoring the safety profile of assigned products.
- Approve rejection of Literature reports not meeting the requirements for capturing in Argus safety database.
- Train and mentor new associates and other Global Line Functions contributing to drug safety evaluation.
- Management of the Corrective Actions and Preventative Actions (CAPA) compilation for global Safety Services team resulting from HA inspections and audits including local global medical service CAPA from Health Authority inspections and audits.
- Alert safety team members to potential safety signals based on incoming case reports.
- PADER Listing generation for Aggregate reporting.
- Quality check of the SDFS (Signal detection Spread sheet) for signal detection.
Safety Processing Expert
Novartis health care private Limited
05.2009 - 01.2011
- Core Pharmacovigilance responsibilities: Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on the regulatory timeliness and quality.
- Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed.
- Work in conjunction with Clinical Safety Associates, Pharmacovigilance Scientists from other processing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and databased.
- As a member of Safety Profiling Teams, ensure that case reports are accurately evaluated and databased, authoring or contributing to Product Guidance Documents for assigned products.
- Work with external partner groups, e.g. co-licensing partners and Clinical Research Organizations to meet joint accountabilities.
- Assist the Medical Safety Physicians in monitoring the safety profile of assigned products.
- Approve rejection of Literature reports not meeting the requirements for Argus safety databasing.
- Train and mentor new associates and other Global Line Functions contributing to drug safety evaluation.
- Management of the Corrective Actions and Preventative Actions (CAPA) compilation for global DS&E resulting from HA inspections and audits including local DS&E CAPA from Health Authority inspections and audits.
- Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the IMS (Integrated Medical Safety) tracking tool and/or safety database.
- Ensure scientific rigor through accurate, complete and consistent data entry of Adverse Event reports from source documents with emphasis on timeliness and quality.
- Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow up requested as needed.
- Alert manager to potential safety signals based on incoming case reports.
Drug Safety Associate
IQVIA
04.2008 - 05.2009
- Core Pharmacovigilance responsibilities: Specialized with oncology, and anti-psychotic products (all spontaneous, literature and clinical trial cases).
- Triage of incoming cases to determine seriousness for prioritization of daily workflow.
- Confirmation of previously entered data and completion of data entry, including writing adverse event case narrative.
- Assess expectedness of adverse events and code approval numbers.
- Complete quality review of own or peer associates’ cases executing literature searches to identify adverse events for inclusion in the worldwide safety database.
- Follow procedures for supporting activities, such as requesting deletions, addition of new code list terms, preparing deviation memos.
- Mentoring the peer associates.
Officer-Regulatory Affairs
Medreich Ltd.
Bangalore
02.2007 - 03.2008
- Responsibilities associated with Core Safety and regulatory submission: Assessment of clinical and non-clinical results of the medicinal products.
- Dossier Preparation and submission to Regulatory authorities.
Education
M. Pharmacy - undefined
Utkal University
01.2006
B. Pharmacy - undefined
Utkal University
01.2004
MBA - undefined
IMT (Institute of Management & Technology)
01.2010
Diploma in Drug laws - undefined
Institute of Pharmaceutical Education and Research
Accomplishments
- Active collaboration with study teams to ensure the project deliverables are delivered within the budget and allocated hours are spent judiciously to ensure all the billable tasks are completed within the stipulated deadlines.
- Helped to identify inefficiencies to remove redundancies like hand-offs, multiple QCs, checklist preparation etc. to improve overall process efficiency and promote First Time Quality (FTQ) by automating certain manual processes.
- Supported increase the EBITDA & profitability of the company by implementing cost-saving measures (for e.g Advance Pricing Agreement).
Personal Information
Title: Associate Director, Safety Operations
Hobbies and Interests
- Swimming
- Gyming
- Marathon run
Disclaimer
I hereby declare that all these information’s furnished by me are true to the best of my knowledge and belief., Hyderabad, 2023-10-01
Skills
Project management
Strategic leadership
Coaching and mentoring
Relationship building
Decision-making
Process improvement
Team collaboration and leadership
Operations management
Technical implementation
Critical thinking
Resources allocation
Negotiation
Employee coaching and mentoring
Managing operations and efficiency
Performance evaluations
Hiring and training
Crisis management
Certification
- PMP, from PMI - 2021-2027
- PMI-ACP, from PMI - 2021-2027
- Lean Six Sigma Black Belt, MSME Technology Development Center - 2021
Interests
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeImportant To Me
Personal development programsCompany CultureCareer advancementTimeline
Associate Director, Safety Operations
PAREXEL International
10.2021 - Current
Senior Manager - Pharmacovigilance Operations
Parexel International
05.2019 - 10.2021
Team Manager - Pharmacovigilance Operations
Parexel International
05.2016 - 04.2019
Associate Team Manager - Pharmacovigilance Operations
Parexel International
05.2013 - 04.2016
Drug Safety Specialist
Parexel International
02.2011 - 05.2013
Safety Processing Expert
Novartis health care private Limited
05.2009 - 01.2011
Drug Safety Associate
IQVIA
04.2008 - 05.2009
Officer-Regulatory Affairs
Medreich Ltd.
02.2007 - 03.2008
M. Pharmacy - undefined
Utkal University
B. Pharmacy - undefined
Utkal University
MBA - undefined
IMT (Institute of Management & Technology)
Diploma in Drug laws - undefined
Institute of Pharmaceutical Education and Research
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