Associate Director of Global Safety and Pharmacovigilance

6 days ago

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

Genmab is seeking an experienced Associate Director of Global Safety and Pharmacovigilance to join our team. As a key member of our Drug Safety and Pharmacovigilance (GDS&PV) team, you will play a critical role in ensuring the safety of our products throughout their lifecycle.

Key Responsibilities
  • Lead Safety-Related Activities: You will lead all major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities for assigned Genmab products.
  • Collaborate with Cross-Functional Teams: You will effectively collaborate with drug safety and cross-functional teams for safety assessments, ongoing surveillance, and related communication around assigned Genmab products.
  • Oversee Safety Issues: You will oversee the handling of safety issues and implement risk mitigation activities.
  • Provide Safety Inputs: You will provide inputs to different documents, such as trial protocols, amendments, and plans, clinical trial reports, eCRFs, and TMFs, based on review.
  • Prepare Safety Documentation: You will prepare relevant documentation, such as benefit/risk sections of aggregate reports, safety summaries, and Q&As, as per regulatory requirements.
  • Manage Forums: You will manage internal and external forums, such as external Data Monitoring Committees and Genmab Safety Committees, for assigned products.
  • Provide Safety Guidance: You will provide guidance, oversight, and training around safety to relevant stakeholders, including Genmab employees, CROs, and Investigators.
  • Engage with Stakeholders: You will proactively engage with internal and external stakeholders, including external experts, partners, and regulatory authorities.
  • Participate in Audits and Inspections: You will take part in audits and inspections.
  • Train and Mentor Teams: You will train and mentor teams on emerging safety aspects and PV processes/technologies/regulations.
Requirements
  • Medical Degree: You must have a medical degree.
  • Experience in Drug Safety/Pharmacovigilance: You must have a minimum of 5+ years' experience in drug safety/pharmacovigilance, covering both clinical development and post-marketing.
  • Solid Clinical Judgment: You must have solid clinical judgment, with experience in oncology being a plus.
  • Experience with PV Audits/Regulatory Authority Inspections: You must have experience with PV audits/regulatory authority inspections and worldwide regulatory authorities' interactions.
  • Experience with Global PV Regulatory Environment: You must have experience with global PV regulatory environment, including regulations, initiatives, standards, and GVP.
  • Experience with Safety Databases and Electronic Data Capture Systems: You must have experience with safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems.
  • Experience Guiding and Mentoring Team Members: You must have experience guiding and mentoring team members.
  • Proven Performance in Earlier Role/Comparable Role: You must have proven performance in an earlier role or comparable role.
About You

We are looking for a passionate and experienced professional who is committed to our purpose and genuinely cares about our mission to transform the lives of patients through innovative cancer treatment. You must be a fierce believer in our rooted-in-science approach to problem-solving and a generous collaborator who can work in teams with diverse backgrounds.

You must be determined to do and be your best and take pride in enabling the best work of others on the team. You must not be afraid to grapple with the unknown and be innovative. You must have experience working in a fast-growing, dynamic company or a strong desire to.

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