Director, Global Drug Safety and Pharmacovigilance
7 days ago
About the Role: As the Director, Global Drug Safety & Pharmacovigilance Physician at Genmab, you will play a critical role in navigating the safety of groundbreaking cancer therapies. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your role involves collaboration with cross-functional teams, leading all aspects of safety issue management, and engaging with regulatory authorities. A profound understanding of global PV regulations, safety databases, and mentorship skills are essential.
Your Responsibilities:
- Lead all major pre- and post-marketing safety-related activities, including signal, benefit-risk evaluation, and risk management activities for your area.
- Effectively collaborate with drug safety and cross-functional teams for safety assessment, ongoing surveillance, and related communication around assigned 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 and 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.
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations.
Requirements:
- An MD with at least 12 years of experience in drug safety/pharmacovigilance, ideally within oncology.
- A seasoned navigator of the global PV regulatory landscape, proficient in audits, inspections, and regulatory authority interactions.
- A strategic thinker with experience in safety databases and electronic data capture systems.
- A leader who guides, mentors, and encourages your team towards excellence.
About Genmab:
Genmab is a biotechnology company that leverages the effectiveness of an agile working environment to promote employee work-life balance. Our offices are designed as open, community-based spaces that foster collaboration and innovation. We thrive on connecting with each other to drive progress and excellence in our field.
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Global Safety and Pharmacovigilance Leader
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Role: As the Director, Global Drug Safety & Pharmacovigilance Physician at Genmab, you will play a critical role in navigating the safety of groundbreaking cancer therapies. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your...
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Global Safety and Pharmacovigilance Leader
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Role: As the Director, Global Drug Safety & Pharmacovigilance Physician at Genmab, you will play a critical role in navigating the safety of groundbreaking cancer therapies. With a Medical Doctorate and over 12 years of experience in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your...
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