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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, 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.