Position Summary 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 general regulations and GVP. 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, and DMC interactions; support FIH and pivotal studies.
- Ensure PV compliance and audit/inspection readiness with vendors and affiliates.
Required
Certifications and Experience - MD, clinical experience is a plus.
- 8–10+ years in pharmacovigilance/drug safety including clinical safety, medical review and signal management.
- Knowledge of GVP, GCP and global safety regulations.
- Strong clinical judgment.
- Fluency in English and good communication skills.