Associate Medical Safety Director

About the role

The Associate Medical Safety Director provides medical expertise for pharmacovigilance activities across clinical trials and post‑marketing projects. Reporting to senior medical safety leadership, the role ensures accurate safety assessment and regulatory compliance for assigned products.

Key responsibilities

• Perform medical review and clarification of trial‑related adverse events (AEs) and post‑marketing adverse drug reactions (ADRs), including narrative, coding, seriousness, causality and expectedness.
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases.
• Serve as internal consultant to case processing teams and provide aggregate safety reviews.
• Review and edit IND Annual Reports, EU Periodic Benefit‑Risk Evaluation Reports, US Periodic Reports, and related regulatory submissions.
• Provide medical oversight for label development, risk management plans, and safety monitoring committee meetings.
• Represent safety findings in client meetings and ensure timely delivery of all medical safety deliverables.

Required profile

• Medical degree (MD) from an accredited, internationally recognized medical school.
• Minimum 7 years of clinical practice experience, including signal management and safety document review.
• Demonstrated experience in pharmacovigilance, adverse event assessment, and regulatory reporting.

Required skills

• Pharmacovigilance
• Adverse Event Coding
• Signal Management
• Risk Management Plan development
• Regulatory Reporting (IND, EU PSUR, US Periodic Reports)
• Medical Review of clinical documents (protocols, IDBs, CRFs)

What we offer

• Opportunity to work on global safety projects with leading pharmaceutical partners.
• Collaborative environment with senior medical safety leaders.
• Professional development in clinical safety and regulatory affairs.