Associate Director – Medical Review Safety Physician

About the role

The Associate Director, Medical Review Safety Physician leads the medical evaluation of safety data from a wide range of sources, ensuring accurate assessment of adverse events for products within the therapeutic area. This senior position contributes to the overall pharmacovigilance process and supports the safety strategy of the division.

Key responsibilities

• Determine the medical and scientific relevance of adverse event reports, including spontaneous, clinical, non‑clinical, and literature sources.
• Perform medical review of Individual Case Safety Reports (ICSRs) across all case types.
• Analyze case‑level and aggregate safety data to identify new safety concerns and trends.
• Communicate findings to the MRSP Team Lead and support the Director, MRSP as needed.
• Participate in matrix management activities such as Safety Management Teams.
• Liaise with MSO, primary MRSP, Molecule Responsible Physician, and Safety Analysis Scientist on ADR determination and RSI table updates.
• Prepare slides for Proactive Safety Review and conduct aggregate data analysis.
• Assess critical cases (e.g., DME, EVOI) and contribute to safety signal evaluation.

Required profile

• Medical degree with board certification and extensive experience in pharmacovigilance.
• Proven ability to interpret clinical data, assess causality, and evaluate safety signals.
• Experience leading safety reviews within a pharmaceutical or biotech environment.
• Strong understanding of regulatory requirements for drug safety reporting.
• Excellent communication skills for cross‑functional collaboration.

Required skills