Senior Director, Medical Safety

Role: Lead global Medical Safety for Pharming, focusing on safety evaluation, benefit/risk assessment, signal detection, and regulatory responses for rare disease therapies. Responsibilities: manage safety risks, oversee signal detection and management, provide medical reviews of adverse event reports, contribute to aggregate safety reports (e.g., PSUR, DSUR), support regulatory interactions, and ensure compliance with pharmacovigilance regulations. Collaborate with Clinical Operations, Medical, Regulatory Affairs, and participate in safety governance bodies. Requirements: MD, DO, or equivalent; at least six years of industry experience in pharmacovigilance and drug safety for both development and marketed products; Board certification and clinical residency preferred. High-Value: rare and ultra-rare diseases, biologics or small molecules, post-market or late-stage development, global regulatory reporting, pharmacovigilance systems, GVP, ICH/GCP guidelines, and cross-functional stakeholder collaboration. Work setup: hybrid (NJ-based) or remote with quarterly NJ travel and additional travel (~10%).