Associate Director, Safety Physician

About the role

The Associate Director, Safety Physician provides medical leadership for patient safety across clinical development and post‑marketing activities. This senior position ensures proactive risk management, compliance with global regulations, and readiness for inspections.

Key responsibilities

• Lead medical review of individual and aggregate safety data and chair safety review meetings.
• Oversee signal detection, evaluation, and benefit‑risk assessments; recommend risk‑minimization actions.
• Author and review DSURs, PBRER/PSURs, RMPs, and labeling updates; support regulatory responses.
• Advise on protocol safety design, stopping rules, and DMC interactions for first‑in‑human and pivotal studies.
• Ensure pharmacovigilance compliance, audit and inspection readiness with vendors and affiliates.

Required profile

• Medical degree (MD) with clinical experience considered a plus.
• 8‑10+ years of experience in pharmacovigilance or drug safety, including clinical safety, medical review, and signal management.
• Strong knowledge of GVP, GCP and global safety regulations.
• Excellent clinical judgment and fluency in English.

Required skills

• Pharmacovigilance
• Drug safety
• Signal detection and management
• GVP (Good Pharmacovigilance Practices)
• GCP (Good Clinical Practice)