Associate Director, Global Drug Safety
2 weeks ago
Genmab is seeking an experienced Associate Director to join our Drug Safety and Pharmacovigilance team. As a key member of our global safety 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- Lead all major pre- and post-marketing safety-related activities, including signal identification and assessment, benefit-risk evaluation, and risk management activities.
- Effectively collaborate with drug safety and cross-functional teams for safety assessments, ongoing surveillance, and related communication around assigned Genmab products.
- Oversee handling of safety issues and implementing risk mitigation activities.
- Provide inputs to different documents, including trial protocols, amendments, and plans, clinical trial reports, eCRFs, and TMFs, based on review.
- Prepare relevant documentation, including benefit/risk sections of aggregate reports and safety summaries, and Q&As as per regulatory requirements.
- Manage internal and external forums, including external Data Monitoring Committees and Genmab Safety Committees, for assigned products.
- Provide guidance, oversight, and training around safety to relevant stakeholders, including Genmab employees, CROs, and Investigators.
- Proactively engage with internal stakeholders, including multidisciplinary project groups, and external stakeholders, including external experts, partners, and regulatory authorities.
- Take part in audits and inspections.
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations.
- MD required.
- Minimum requirement: 5+ years' experience in drug safety/pharmacovigilance covering both clinical development and post-marketing.
- Solid clinical judgment: experience in oncology is a plus.
- Experience with PV audits/Regulatory Authority Inspections and worldwide regulatory authorities' interactions.
- Experience with global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA and WHODrug coding dictionaries.
- Experienced in 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.
- Experience guiding and mentoring team members.
- Proven performance in earlier role/comparable role.
- Self-driven learner, pragmatic, problem solver, and curious.
- Team player, focused on the overall success of the team, the project, and Genmab.
- Strong communicator and good at building professional relations to colleagues, collaborators, and business partners.
- Proactive and able to prioritize work in a fast-paced and changing environment.
- Result- and goal-oriented.
- Able to express own opinion with supporting arguments and facts.
- Thrive in a multicultural environment.
Genmab offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment, we encourage you to apply.
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