Director, Global Drug Safety & Pharmacovigilance Physician

Role: GDS & PV Physician, Director level, providing global safety oversight for Genmab’s biologic products throughout their lifecycle, with a focus on oncology. Responsibilities: lead safety activities including signal detection, benefit-risk evaluation, and risk management; collaborate cross-functionally for safety assessments, document preparation, and communication; oversee safety issues and mitigation strategies; contribute to regulatory documentation; manage safety forums, and mentor colleagues. Requirements: MD with 12+ years in drug safety/pharmacovigilance, preferably in oncology; experience with BLA/NDA submissions, regulatory inspections, and global PV regulations; proficiency with safety databases (e.g., ARISg, ARGUS), MedDRA, WHODrug, and electronic data capture; demonstrated leadership and mentoring skills. High-value: biologics, oncology, lifecycle safety management, global regulatory engagement, active participation in inspections, and PV system expertise. Work setup: role is based in the U.S., with a salary range of $235,840–$353,760; comprehensive benefits package.