Associate Director, Global Drug Safety & Pharmacovigilance Scientist
About the position Responsibilities • Perform safety review of Adverse Event reports for Genmab products. • Conduct ongoing surveillance (including signal detection/evaluation) of safety data from Genmab clinical trials. • Serve as the primary safety contact for other departments and ensure appropriate handling of safety issues. • Provide safety review and input to various documents including Trial Protocols, eCRFs/CRFs, and TMFs. • Contribute to the development of documentation such as Investigator's Brochures and Development Safety Update Reports. • Establish and manage external Data Monitoring Committees (DMCs) for early phase trials. • Contribute to the planning and conduct of Safety Committee activities. • Conduct safety training for Genmab employees, CROs, Investigators, and relevant site personnel. • Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products. • Interact with safety and clinical CROs, perform sponsor oversight activities for safety-related tasks, and ensure regulatory compliance. • Oversee Safety Data Exchange Agreements with partners as required. • Collaborate with external experts and partners. • Perform ongoing surveillance of new and updated regulations/guidelines and assess their impact on drug safety processes at Genmab. • Ensure compliance with regulatory guidelines and internal processes in preparation for audits and inspections. • Participate in audit and inspection activities as required. Requirements • Bachelor of Science in Pharmacy, Chemistry, Nursing, or a related natural sciences field, or the foreign degree equivalent. • At least 5 years of progressive, post-baccalaureate experience in drug safety and/or pharmacovigilance. • Experience with first human trials and overseeing multiple trials with safety inputs at the global level. • International experience with internal and external stakeholders. • Experience performing ongoing surveillance (including signal detection/evaluation) of safety data. • Experience ensuring compliance with regulatory guidelines and internal processes in preparation for audits and inspections. Nice-to-haves • Experience working in a fast-growing, dynamic company. • Strong desire to innovate and problem-solve in a scientific context. Benefits • Competitive salary and benefits package. • Hybrid work model allowing for remote work within commuting distance. • Opportunities for professional development and training. Apply tot his job Apply tot his job