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 global 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.
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