Associate Director, Safety Physician
Core
Provide medical leadership for patient safety across clinical development and post-marketing, overseeing risk management and regulatory compliance for assigned products.
Role type
Associate Director, Safety Physician
Builds
Safety strategies, regulatory submissions, and risk minimization plans for pharmaceutical products
Domain
Pharmaceuticals / Pharmacovigilance
Required skills
Medical review of safety data, signal detection and evaluation, benefit-risk assessment, aggregate reporting (DSUR, PBRER/PSUR), regulatory compliance (GVP, GCP), protocol safety design, inspection readiness
Preferred skills
MD degree, clinical experience
Technologies
GVP, GCP
Responsibilities
Lead medical review of individual and aggregate safety data; oversee signal detection/evaluation and benefit–risk assessments; author/review regulatory safety documents; advise on protocol safety design and DMC interactions; ensure PV compliance and audit/inspection readiness
Seniority
Senior, hands-on IC
