Vice President, Global Qualified Person for Pharmacovigilance (Global QPPV) in Copenhagen, Capital, Denmark | Development at Genmab

Vice President, Global Qualified Person for Pharmacovigilance (Global QPPV) in Copenhagen, Capital, Denmark | Development at Genmab Skip to main content Skip to main content Healthcare Professionals Patients & Care Partners Partnerships Contact Working at Genmab Career Areas Application Process Locations Talent Community Job Search Corporate Sign in Close the popup Sign in to Phenom Careers Enjoy a personalized jobs search Sign in with Google Employee Login Sign in with Google Sign up Saved jobs (0) Healthcare Professionals Patients & Care Partners Partnerships Contact Saved jobs (0) Toggle navigation - - Recruitment Fraud Warning: Please note that Genmab never requests payment, banking details, or Social Security numbers during the recruitment process. All legitimate job opportunities are listed exclusively on our Careers page at https://careers.genmab.com. 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Close Covid-19 banner Vice President, Global Qualified Person for Pharmacovigilance (Global QPPV) Location Copenhagen, Capital, Denmark Category Development Job Id R17155 Hybrid Save Apply Now We are extra[not]ordinary*(ex· tra· not· or· di· nary |\ ik- str-not- r-d - ner- ) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and authentic Back to search results Previous job Next job JOB DESCRIPTION At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role The VP, Global QPPV is responsible for oversight of the Genmab global pharmacovigilance (PV) system and serves as the statutory EU Qualified Person for Pharmacovigilance (QPPV). The role operates within a distributed Model PV organization, with central governance through the QPPV Office and execution through Affiliate PV Oversight (APVO) and local PV structures. This role offers a unique blend of strategic leadership and hands-on execution in a biotech environment characterized by agility, innovation, and scientific depth. Responsibilities Establishing and maintaining oversight of the global PV system Ensure that an effective and robust pharmacovigilance system is in place in compliance with applicable global regulatory requirements (EU, FDA, ICH, and other regions) Oversee processes for: - Collection, assessment, and reporting of adverse events - Signal detection and management - Aggregate reporting (PSUR/PBRER, DSUR) - Risk management activities Ensure the PV system is inspection-ready at all times EU QPPV responsibilities Serve as the EU QPPV and fulfill all regulatory obligations Maintain and approve the Pharmacovigilance System Master File (PSMF) Ensure the PSMF is available to competent authorities upon request Act as primary contact with EMA and EU/EEA regulatory authorities Ensure timely and accurate responses to health authority requests Leadership of the QPPV Office: Establish and maintain the QPPV Office as the central governance function for PV Define standards and frameworks for: - Global and local QPPV roles - Escalation pathways - PV governance and decision-making Provide a forum for alignment, communication, and escalation across local QPPVs Oversight of Affiliate PV model: Provide oversight across: - Affiliate PV Oversight (APVO) - Local QPPVs and PV representatives - Distributors and external partners Ensure clear delineation of responsibilities between governance (QPPV Office) and execution (APVO/local PV) Maintain visibility over PV compliance and performance across all regions Collaboration with Affiliate PV Oversight (APVO): Partner with APVO to ensure appropriate local PV structures and resourcing Support oversight of: - Local PV compliance - PV Agreements (PVAs) - Distributor PV responsibilities Ensure effective escalation and resolution of local PV issues Medical oversight of product safety: Maintain oversight of benefit-risk profiles across the product portfolio Collaborate with Safety Physicians and Surveillance teams Contribute to: - Signal evaluation and prioritization - Risk management strategies - Preparation of regulatory safety reports Inspection, audit and compliance: Support and lead PV inspections by regulatory authorities Collaborate with Quality Assurance on PV audit strategy Review and approve CAPAs for major and critical findings Monitor PV compliance and performance metrics PV system architecture and scalability: Ensure PV infrastructure supports global expansion and product launches Oversee alignment of global and local PV requirements Provide input into decisions on: - Outsourcing versus internal resourcing - Local PV operating models Deputy QPPV: Ensure a suitably qualified Deputy QPPV is appointed Maintain continuity of PV oversight, including 24/7 availability Key Requirements Medical Doctor (MD) required Extensive experience in pharmacovigilance (15+ years preferred) Prior experience as EU QPPV or Deputy QPPV is required on a global level Strong understanding of global pharmacovigilance regulations Experience managing global and distributed PV systems Experience working with affiliates, local PV structures, and distributors Proven track record in regulatory inspections Ability to influence senior stakeholders across a matrix organization Demonstrates strategic agility with a “roll-up-your-sleeves" approach Operates effectively a in a dynamic, high-growth biotech environment while maintaining scientific and operational rigor The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK1.200.000,00---1.800.000,00 The final salary offer will depend on several factors, including your skills, qualifications, and experience. In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to: Pension Health insurance and wellness benefits Paid time off Employee support programs Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a