Position Summary / Mission

The Associate Director, Safety Physician provides medical leadership for patient safety across clinical development and post‑marketing for assigned products. The role oversees medical review, signal detection/management, aggregate reporting, and benefit–risk assessment in compliance with global regulations and GVP. The incumbent partners with Clinical, Regulatory and Medical Affairs to ensure proactive risk management, timely safety communications, and inspection readiness, and also engages with health authorities as needed.

Core Responsibilities

• Lead medical review of individual and aggregate safety data; chair or contribute to safety review meetings.
• Oversee signal detection/evaluation and benefit–risk assessments; recommend risk minimization actions.
• Author/review DSURs, PBRER/PSURs, RMPs, and labeling updates; contribute to regulatory responses.
• Advise on protocol safety design, stopping rules...