Global Drug Safety Physician Leader
2 weeks ago
Genmab is committed to developing innovative cancer treatments that change the lives of patients.
As a seasoned Pharmacovigilance Expert, you will lead critical safety evaluations and risk management activities for our ground-breaking cancer therapies. We're looking for a seasoned Medical Doctor with over 12 years of experience in drug safety/pharmacovigilance, ideally within oncology.
Key Responsibilities:
- Lead all major pre- and post-marketing safety-related activities, including signal, benefit-risk evaluation, and risk management activities for assigned Genmab products.
- Collaborate with cross-functional teams for safety assessment, ongoing surveillance, and related communication around Genmab products.
- Be responsible for handling safety issues and implementing risk mitigation activities, and propose systemic solutions.
- Provide inputs to different documents, such as trial protocols, amendments, and plans, clinical trial reports, eCRFs/CRFs, TMFs, based on review.
- Prepare relevant documentation, such as benefit/risk sections of aggregate reports, safety summaries, as per regulatory requirements.
- Lead internal & external forums, such as external Data Monitoring Committees (DMCs), Genmab Safety Committees, for assigned products.
- Provide guidance, oversight, and training around safety to relevant collaborators, such as Genmab employees, CROs, Investigators.
- Proactively engage with internal team members and external collaborators around emerging landscape, regulatory authorities around audits and inspections.
Requirements:
- MD with at least 12 years of experience in drug safety/pharmacovigilance, ideally within oncology.
- Seasoned navigator of the global PV regulatory landscape, proficient in audits, inspections, and regulatory authority interactions.
- Strategic thinker with experience in safety databases and electronic data capture systems.
- Leader who guides, mentors, and encourages teams towards excellence.
About Us:
- We're passionate about transforming the lives of patients through innovative cancer treatments.
- We bring rigor and excellence to all that we do, and are a fierce believer in our science-driven approach to problem-solving.
- We're a generous collaborator who can work in teams with diverse backgrounds.
- We're determined to do and be our best, and take pride in enabling the best work of others on the team.
- We're not afraid to grapple with the unknown and be innovative.
- We work hard and are not afraid to have a little fun while we do so.
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