Overview

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!Director, Global Drug Safety & Pharmacovigilance ComplianceThe RoleEstablishing a US-based Pharmacovigilance (PV) Compliance Director position will strengthen global compliance capabilities, provide essential support across multiple time zones, improve responsiveness to audits and inspections, and ensure consistent compliance oversight for GDS&PV's global development and post-marketing activities.ResponsibilitiesEnsure appropriate establishment and execution of all global pharmacovigilance procedures working closely with global colleagues from other departments/regions as applicable.Support with overseeing and maintaining global pharmacovigilance policies, procedures, and workflows, including development and implementation of SOPs and other controlled documents support with investigational and marketed product safety surveillance.Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.Responsibilities- Act as the lead US for PV audits and inspections, overseeing preparation, conduct, responses, and post-audit/inspection actions:Coordinate and support GDS&PV preparation activities for internal audits, partner audits, and health authority inspections.Maintain audit and inspection trackers, action lists, and timelines.Support scheduling of audit/inspection meetings, interviews, training and readiness activities.Coordinate collection, organization, and version control of requested documentation.Track and follow up on audit/inspection actions and commitments in collaboration with GDS&PV compliance and process owners and cross-functionally.Coordinate and support Quality Events creation, follow-up, and timely closure.Support inspection readiness activities (e.g. quarterly internal compliance health checks on key PV processes, evidence repositories, story boards, trackers, lessons learned).- Manage and oversee the GDS&PV Quality Event process resulted from continuous compliance monitoring and work closely with Global QA to address and document responses and provide feedback to ensure adherence to the internal and external guidance documents, and SOPs.- Co-representing Global GDS&PV Compliance in relevant end-to-end process execution activities and governance forums. Governance and Oversight- Work with the other GDS&PV Compliance teams to ensure that safety/PV training is provided to all relevant global internal and external employees and 3rd parties.- Ensure compliance with regulatory authority guidelines and regulations as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations.- Provide support to the global GDS&PV team with compliance oversight relevant to the regions in compliance with current regional regulations, internal and external guidance documents, and SOPsRequirements- Advanced degree in healthcare related field- Minimum requ