Director, Global Patient Safety Sciences - General Medicine

Role: Serve as Global Patient Safety (GPS) Lead for assigned assets, overseeing safety surveillance, signal detection, benefit-risk assessments, safety communications, and regulatory safety documents across the product lifecycle. Responsibilities: lead safety strategy, manage cross-functional safety teams, represent GPS in key safety committees and external collaborations, provide medical review of safety data, and ensure compliance with FDA, EU, and ICH regulations; contribute to SOP development and safety process improvements; mentor junior staff. Requirements: minimum 10+ years in pharmacovigilance or relevant medical field, with 5+ years in drug safety; advanced degree (PharmD, PhD, MD); industry experience in oncology preferred; deep knowledge of regulatory guidance and safety database systems. HighValue: global drug safety, post-marketing surveillance, signal management, benefit-risk assessment, regulatory safety reporting, experience with PSURs/DSURs/RMPs, therapeutic area expertise in oncology, leadership in safety teams. WorkSetup: hybrid (Tarrytown, NY or Warren, NJ), 4 days onsite; travel requirements not specified.