Director, Global Drug Safety & Pharmacovigilance Physician

Role: Senior Drug Safety & Pharmacovigilance (GDS&PV) Physician at Director level, responsible for overseeing global safety strategies and safety profile management for Genmab's antibody therapies throughout their lifecycle. Responsibilities: lead safety activities including signal detection, benefit-risk evaluation, risk mitigation, and preparation of safety documentation; collaborate with cross-functional teams; manage safety issues and communication with regulatory authorities; mentor junior staff and provide PV training; engage with external stakeholders, including Data Monitoring Committees and regulatory agencies. Requirements: MD with 12+ years in drug safety/pharmacovigilance, especially in oncology; experience with BLA/NDA submissions, PV audits, FDA and global regulatory environments; proficiency with safety databases (ARISg, ARGUS) and coding standards (MedDRA, WHODrug). Preferred: experience guiding teams, active participation in regulatory inspections. HighValue: oncology, biologics, antibody therapeutics, lifecycle safety management, global PV regulation, regulatory documentation, safety database expertise, stakeholder engagement. WorkSetup: not specified; role involves international engagement.