Safety Physician

Medical Director, Pharmacovigilance – Contract Position Summary An opportunity is available for an experienced Medical Director to provide medical safety leadership across an approved product and ongoing clinical development programs. The role will focus on pharmacovigilance strategy, integrated safety assessments, and supporting NDA submissions, regulatory reviews, and post approval safety activities.

Key Responsibilities

Lead signal detection, evaluation, and medical review of safety data across clinical trials, individual case reports, and published literature. Drive integrated safety assessments and contribute to key regulatory submission documents, including the Integrated Summary of Safety (ISS) and benefit–risk evaluations. Partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Medical Writing to ensure consistent safety narratives and submission readiness. Evaluate adverse events, dose optimization, and emerging safety signals to inform clinical and regulatory decisions. Support FDA interactions, regulatory responses, labeling discussions, and risk management activities. Provide medical oversight of safety deliverables, external consultants, and submission timelines.

Required Qualifications

MD, DO, or equivalent medical degree. 10+ years of experience in pharmacovigilance or clinical safety. Direct experience contributing to the safety components of at least two NDA or BLA submissions, including integrated safety assessments and regulatory responses. Strong expertise in signal evaluation, aggregate safety reporting, benefit–risk assessment, and interpretation of clinical safety data. Experience partnering with Biostatistics and Medical Writing on regulatory submission documents. Strong communication skills and ability to operate effectively in a cross-functional, deadline-driven environment.

Preferred Qualifications

Oncology development experience, including combination therapies and dose optimization. Experience supporting FDA meetings, labeling negotiations, and advisory committee preparation. Familiarity with postmarketing safety surveillance and risk management strategies.