Domnic Lewis has been mandated to hire for AM Pharmacovigilance
Organizational Context
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Department:
Regulatory Affairs & Market Access - India
Primary Reporting Line:
Senior Manager - Regulatory & Pharmacovigilance
Dotted-Line Reporting:
EU Qualified Person for Pharmacovigilance (EU QPPV)
Geographic Responsibility
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Country:
India
Mission
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The Deputy Local Pharmacovigilance Responsible Person is responsible for supporting and ensuring the effective management of Pharmacovigilance (PV) activities for all products marketed or used in clinical trials in India, in compliance with local regulatory requirements and global pharmacovigilance standards.
Key Responsibilities
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1. Local Pharmacovigilance System
Support the establishment, implementation, and maintenance of a robust local Pharmacovigilance system.
Coordinate PV activities at the national level in collaboration with Local PV, Global Safety, and cross-functional stakeholders.
Ensure continuous oversight of the safety profile of the product portfolio.
as required by local regulations.
Support the Local PV Responsible Person in fulfilling regulatory obligations and responding to authority requests.
3. Case Management
Ensure management and processing of Individual Case Safety Reports (ICSRs) from all sources in accordance with internal procedures and local/global regulatory requirements.
Ensure accurate and timely safety data entry and reporting in the safety database.
4. Pharmacovigilance System Master File (PSMF)
Support maintenance and availability of the PSMF or equivalent local documentation, as required by local regulations.
5. Literature Surveillance
Ensure regular screening of local and scientific literature.
Perform case identification, processing, and reporting of safety information derived from literature sources.
6. Interface Management
Ensure oversight, coordination, and reconciliation of all internal and external interfaces that may generate PV data (e.g., Medical, Regulatory, Quality, Commercial, vendors).
7. Study and Program Oversight
Ensure appropriate safety reporting processes for interventional and non-interventional studies, compassionate use programs, and other safety-relevant programs at the local level.
Ensure alignment with global processes and local regulatory requirements.
8. Aggregate Reports and Periodic Safety Updates
Ensure compliance with preparation, review, and submission of aggregate safety reports (e.g., PSURs/PBRERs) as per local regulatory timelines and requirements.
9. Risk Management
Oversee implementation and local execution of Risk Management Plans (RMPs) and additional Risk Minimization Measures (RMMs) as required.
10. Signal Detection
Perform and support local signal detection activities.
Escalate any potential local safety signals to Global Safety in a timely manner.
11. Safety Communication and Regulatory Interactions
Manage responses to safety-related queries from National Competent Authorities.
Support local and global safety communications to healthcare professionals or consumers, when applicable.
Provide necessary information to the EU QPPV office to support global oversight activities.
Maintain up-to-date knowledge of local pharmacovigilance regulations.
12. Labeling and Safety Commitments
Contribute to local safety labeling updates in collaboration with Regulatory Affairs.
Support implementation and tracking of post-authorization safety commitments, as applicable.
13. Pharmacovigilance Quality System
Ensure implementation and maintenance of a local PV Quality System aligned with global standards and local regulatory requirements.
Ensure training and awareness of PV obligations for relevant internal staff and external partners.
Maintain training compliance records and metrics.
14. Pharmacovigilance Agreements
Inform Global Safety of all local contracts impacting pharmacovigilance activities.
Ensure compliance with Pharmacovigilance Agreements (PVAs).
Communicate changes affecting PV responsibilities or products covered by agreements in a timely manner.
15. Business Continuity
Ensure continuity of PV activities, including arrangements for out-of-hours coverage and backup processes.
16. Regulatory Intelligence
Monitor updates to local pharmacovigilance legislation.
Conduct impact assessments and communicate relevant changes to Global Safety.
17. Documentation and Archiving
Ensure PV documentation is archived in compliance with local regulations and data protection requirements.
18. Audits and Inspections
Act as a local PV contact during audits and inspections.
Coordinate with Global Safety and Local PV on inspection readiness.
Ensure implementation of Corrective and Preventive Actions (CAPAs) within agreed timelines.
19. Quality Management and SOPs
Develop and maintain local SOPs and operational procedures related to India-specific pharmacovigilance requirements.
Act as Deputy LPV for local PV activities, including:
+ ICSR processing and reporting
+ Literature screening
+ Safety database management
+ Liaison with healthcare professionals for AE collection
+ Submission of safety reports to local authorities
+ Training and mentoring of PV team members
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