Associate Director, Global Drug Safety & Pharmacovigilance Scientist

Genmab US, Inc.Associate Director, Global Drug Safety & Pharmacovigilance ScientistPlainsboro, New JerseyPOSITION DUTIES: Perform safety review of Adverse Event reports for Genmab products. Perform ongoing surveillance (including signal detection/evaluation) of safety data from Genmab clinical trials. Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues. Provide safety review and input to various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs. Contribute to the development of other documentation such as: Investigator’s Brochures, Subject Informed Consent, 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 of Genmab employees, CROs, Investigators and other relevant site personnel as necessary. Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products. Contribute to the development and optimization of new tools and process. Interact with safety and clinical CROs, perform sponsor oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products. 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 the impact on drug safety processes at Genmab. Ensure compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections. Participate in audit and inspection activities as required. Position is hybrid and allows working from home within commuting distance of worksite location. This position requires limited domestic and international travel to client sites.Please note that Genmab will always pay or exceed the prevailing wage, as determined by the U.S. Department of Labor, when applicable.POSITION REQUIREMENTS: The qualified candidate must have at least a Bachelor of Science in Pharmacy, Chemistry, Nursing, or a related natural sciences field, or the foreign degree equivalent. The qualified candidate must have at least 5 years (60 months) of progressive, post-baccalaureate experience with all the following: (a) first human trials; (b) overseeing multiple trials with safety inputs at the global level; (c) international experience with internal and external stakeholders; (d) drug safety and/or pharmacovigilance experience; (e) performing ongoing surveillance (including signal detection/evaluation) of safety data; and (f) ensuring compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections. All experience may be gained concurrently.Interested applicants should send cover letter + resume to:Dawn KesslerDirector, Site HR Lead USGenmab US, Inc.777 Scudders Mill Rd, Bldg. 2, 4th FlPlainsboro, NJ 08536Phone: (609) 430-2481Email: dake@genmab.com