Global Safety Physician Leader
6 days ago
We are seeking a highly skilled and experienced Director, Safety Surveillance Physician to join our team at Genmab. As a key member of our Drug Safety & Pharmacovigilance (GDS&PV) team, you will play a critical role in contributing to the global safety strategy and overall safety profile for our assigned products throughout their lifecycle.
Key Responsibilities- Effectively interact cross-functionally at all levels in the organization, as well as with external parties, including Regulatory Authorities, as applicable.
- Work together with other Drug Safety staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders.
- Lead all major pre- and post-marketing safety-related activities, including signal, benefit-risk evaluation, and risk management activities for own area.
- Collaborate with drug safety and cross-functional teams for safety assessment, ongoing surveillance, and related communication around assigned Genmab products.
- Oversee handling of safety issues and implementing risk mitigation activities, and propose systemic solutions.
- Provide inputs to different documents, such as trial protocols, amendments, and plans, clinical trial reports, and prepare relevant documentation as per regulatory requirements.
- Manage internal and external forums, including external Data Monitoring Committees (DMCs), and provide guidance, oversight, and training around safety to relevant stakeholders.
- 12+ years of experience in drug safety/pharmacovigilance in clinical development and post-marketing, preferably in oncology.
- Experience with PV audit process, including active participation in Regulatory Authority Inspections, and working with the FDA and other regulatory authorities.
- Experience with global PV regulatory environment, including regulations, initiatives, standards, GVP, MedDRA, and WHODrug coding dictionaries, and individual adverse event case report processing, triage, and medical review.
- Experience with safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems preferred.
- Proven performance in earlier role/comparable role.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We leverage the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. We are an equal opportunities employer and welcome applications from all qualified candidates.
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