Associate Director, Global Safety Expert

6 days ago

Plainsboro, New Jersey, United States Genmab Full time
About the Role

We are seeking a highly skilled and experienced Associate Director to join our Global Drug Safety team at Genmab. As a key member of our team, you will be responsible for leading major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.

Key Responsibilities
  • Collaborate with cross-functional teams to conduct safety assessments, including review of adverse events and scientific literature, and prepare safety reports.
  • Oversee the handling of safety issues and implement risk mitigation activities.
  • Provide inputs to various documents, including trial protocols, amendments, and plans, clinical trial reports, and benefit-risk sections of aggregate reports.
  • Manage internal and external forums, including external Data Monitoring Committees, and provide guidance and oversight on safety to relevant stakeholders.
  • Participate in audits and inspections.
Requirements
  • 5+ years of experience in drug safety/pharmacovigilance, covering both clinical development and post-marketing.
  • Solid clinical judgment, with experience in oncology a plus.
  • Experience with PV audits, regulatory authority inspections, and worldwide regulatory authorities' interactions.
  • Experience with global PV regulatory environment, including regulations, initiatives, standards, and GVP.
  • Proficiency in MedDRA and WHODrug coding dictionaries.
  • Experience with individual adverse event case report processing, triage, and medical review.
  • Experience with safety databases and electronic data capture systems preferred.
About Genmab

Genmab is an international biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. We have a strong focus on diversity, equity, and inclusion, and we believe that it is essential for our continued success.

We are committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application.

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