Associate Director, GDS&PV Signal Detection Specialist

16 hours ago


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

We are seeking an experienced Associate Director to join our team at Genmab, a leading biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment. As a key member of our Pharmacovigilance team, you will play a critical role in the detection and evaluation of new safety signals and emerging trends from clinical and post-marketing safety data.

Key Responsibilities
  • Develop and implement product-specific surveillance plans to proactively detect and evaluate new safety signals and emerging trends.
  • Conduct systematic reviews of aggregate data, including spontaneous adverse event reports, to identify and assess new safety signals and trends.
  • Provide medical opinion and safety input to regulatory authorities, IRBs, and other stakeholders.
  • Collaborate with cross-functional teams to develop and implement signal evaluation strategies and participate in signal evaluation activities.
  • Communicate findings from routine and ad-hoc signal detection and assessment activities to stakeholders.
Requirements
  • Advanced Healthcare-related Degree (e.g., RN, PA, PharmD) with a minimum of 5+ years of industry experience in drug safety or a related area.
  • Understanding of global health authority regulations and guidances surrounding the processing, reporting, and evaluation of adverse events.
  • Ability to present complex data in a concise and understandable scientific manner.
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. We are committed to fostering workplace diversity and believe it is essential for our continued success.



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