Associate Medical Safety Director

About the role

The Associate Medical Safety Director provides medical expertise on pharmacovigilance services across divisions and supports safety oversight on assigned clinical trials and standalone safety projects. The role works under the guidance of senior medical safety directors to ensure regulatory compliance and patient safety.

Key responsibilities

• Perform medical review and clarification of trial‑related adverse events (AEs) and post‑marketing adverse drug reactions (ADRs), including narrative content, queries, coding, expectedness, seriousness, causality and company summary.
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases.
• Serve as internal consultant to pharmacovigilance case processing teams and provide aggregate safety reviews.
• Review and edit regulatory documents such as IND Annual Reports, EU Periodic Benefit‑Risk Evaluation Reports, US Periodic Reports, Development Risk Management Plans, and Risk Evaluation and Mitigation Strategies.
• Provide medical oversight for label development, Data Safety Monitoring Board meetings, safety monitoring committees, and integrated safety summaries.
• Sign off on Project Safety Plans and Medical Monitoring Plans, and ensure coverage of all medical safety deliverables within contractual timelines.

Required profile

• Medical degree (MD) from an accredited, internationally recognized medical school.
• Minimum 7 years of clinical practice experience, including signal management and clinical trial document review.
• Demonstrated ability to perform medical safety reviews, coding verification, and regulatory document preparation.

Required skills