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Senior Director, Global Drug Safety

1 month ago

Princeton Meadows, New Jersey, United States Genmab Full time
About the Role

Genmab is seeking a highly experienced Senior Director, Global Drug Safety to join our team. As a key member of our Global Drug Safety and Pharmacovigilance team, you will be responsible for leading the development and implementation of our global safety strategy and ensuring the overall safety profile of our assigned products.

Key Responsibilities
  • Develop and implement the global safety strategy for assigned products
  • Lead the safety assessment of products, including review of individual and aggregate adverse events and scientific literature
  • Prepare and communicate safety reports to internal and external stakeholders
  • Collaborate with cross-functional teams to ensure the safety of our products
  • Ensure compliance with regulatory guidelines and internal procedures
Requirements
  • MD required; clinical research and/or fellowship training in oncology/hematology, pharmacology or other relevant specialty is a plus
  • Minimum 10 years Drug Safety/Pharmacovigilance experience plus 2 years clinical development experience; other relevant experience may be considered
  • Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP)
  • Exposure to working relationship with the FDA and other regulatory authorities is preferred
About Genmab

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.