Accountable for the medical review function of a large OTC/consumer healthcare pharmacovigilance program handling large volume cases per year. Reports to the Director Safety and leads the medical review team, owning the medical quality and clinical judgment applied across the case and aggregate report portfolio.
Key Responsibilities:
1. Lead and own the medical review function across the case processing and aggregate report portfolio.
2. Manage a team of drug safety physicians, ensuring consistency and quality of medical judgment.
3. Provide medical review for serious cases and line listing review for non-responsible cases in line with program SOPs.
4. Own causality, seriousness, and expectedness assessment standards across the operation.
5. Provide medical input and benefit-risk evaluation for aggregate reports.
6. Serve as the senior medical point of contact for the client and respond to medical aspects of regulatory queries.
7.
Support signal assessment and product safety evaluation for the consumer health portfolio.
8. Ensure the medical review function remains inspection-ready and support regulatory inspections and audits.
Key Skills - Medical review leadership | Drug safety physician expertise | Causality and benefit-risk assessment | Line listing review | Aggregate report medical input | Product safety | Consumer health and OTC | Regulatory query response | Team leadership
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