Senior Medical Director of Global Safety
7 days ago
Genmab is seeking a highly skilled and experienced Associate Director to join our Drug Safety and Pharmacovigilance team. As a key member of our global safety strategy, you will be responsible for ensuring the safe and effective development and marketing of our products.
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, such as trial protocols, amendments, and plans, clinical trial reports, eCRFs, and TMFs, based on review.
- Prepare relevant documentation, such as benefit/risk sections of aggregate reports, safety summaries, and Q&As, as per regulatory requirements.
- Manage internal and external forums, such as 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, such as multidisciplinary project groups, and external stakeholders, such as 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.
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