Director, Global Drug Safety & Pharmacovigilance Compliance

Role: Establish and lead US-based Pharmacovigilance (PV) Compliance to strengthen global PV oversight for Genmab's development and post-marketing activities. Responsibilities: oversee PV audit/inspection preparation and execution, maintain compliance documentation, support inspection readiness, manage quality events, and ensure adherence to regional and global PV regulations. Additionally, act as a global PV compliance representative in governance forums and ensure PV training for internal and external stakeholders. Requirements: advanced healthcare degree, 12+ years in PV/Clinical Research, extensive experience managing PV processes, audits, and compliance systems, with knowledge of FDA/EMA/PMDA/ICH regulations. Preferred: proven leadership in PV, training skills, and familiarity with pharmacovigilance trends. High-Value: emphasis on global PV compliance, audits, inspections, and regulatory oversight in a biotech setting. Work setup: flexible work arrangement with 20-40% remote work, based in the US.