Safety Director, Global Drug Safety Expert
1 week ago
About the Role:
As a seasoned Pharmacovigilance Physician, you will lead critical safety evaluations and risk management activities for Genmab's groundbreaking cancer therapies. With a Medical Doctorate and over 12 years in drug safety, ideally in oncology, you will navigate the complexities of global PV regulations, safety databases, and mentorship skills. Your role involves collaboration with cross-functional teams, strategic thinking, and effective communication with regulatory authorities.
Your Key Responsibilities:
- Develop and implement safety strategies for assigned Genmab products, ensuring compliance with global PV regulations and best practices.
- Collaborate with drug safety and cross-functional teams to assess safety risks, review adverse event reports, and develop risk mitigation plans.
- Provide guidance, oversight, and training on safety protocols, PV processes, and emerging safety aspects to relevant stakeholders.
- Lead internal and external forums, such as Data Monitoring Committees and Genmab Safety Committees, to ensure effective safety oversight and risk management.
- Engage with regulatory authorities, external experts, and partners to stay up-to-date on emerging safety trends and regulations.
Requirements:
- MD with at least 12 years of experience in drug safety/pharmacovigilance, ideally within oncology.
- Strategic thinker with experience in safety databases, electronic data capture systems, and global PV regulations.
- Effective communicator with excellent leadership, mentorship, and collaboration skills.
- Ability to work in a fast-paced, dynamic environment and adapt to changing priorities and regulations.
About Genmab:
Genmab is a pioneering biotech company committed to developing innovative cancer therapies and transforming the lives of patients. We offer a collaborative, agile work environment that values diversity, innovation, and excellence. If you are passionate about our purpose and committed to delivering exceptional results, we encourage you to apply for this exciting opportunity to shape the future of oncology treatments.
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