Global Safety and Pharmacovigilance Leader
2 months 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 safety aspects and PV processes/technologies/regulations.
- 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 committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our company culture is built on being proudly unique, determined to be our best, and authentic, which is essential to fulfilling our purpose.
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Global Safety and Pharmacovigilance Leader
2 months 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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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our organization, you will be responsible for leading critical safety evaluations and risk management activities for our innovative cancer therapies.Key ResponsibilitiesLead all major pre- and...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our organization, you will be responsible for leading critical safety evaluations and risk management activities for our innovative cancer therapies.Key ResponsibilitiesLead all major pre- and...
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Director, Global Drug Safety and Pharmacovigilance
2 months 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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