Director, Global Safety and Pharmacovigilance
6 days ago
Genmab is seeking a highly skilled and experienced Director, Global Safety and Pharmacovigilance to join our team. As a key member of our safety and pharmacovigilance department, you will be responsible for leading the development and implementation of safety strategies for our products, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to ensure the safe and effective use of our products.
Key Responsibilities- Lead Safety Strategies: Develop and implement safety strategies for our products, including signal detection, benefit-risk evaluation, and risk management.
- Collaborate with Cross-Functional Teams: Work closely with our clinical development, regulatory, and commercial teams to ensure the safe and effective use of our products.
- Ensure Regulatory Compliance: Ensure compliance with regulatory requirements, including those related to pharmacovigilance, clinical trials, and product labeling.
- Manage Safety Databases: Oversee the management of safety databases, including the collection, analysis, and reporting of adverse event data.
- Train and Mentor: Train and mentor junior colleagues on safety and pharmacovigilance principles and practices.
- MD Required: A medical degree is required for this position.
- Experience in Drug Safety/Pharmacovigilance: A minimum of 12+ years of experience in drug safety/pharmacovigilance in clinical development and post-marketing, preferably in oncology.
- Regulatory Experience: Experience with PV audit process, regulatory authority inspections, and working with the FDA and other regulatory authorities.
- Global PV Regulatory Environment: Experience with global PV regulatory environment, including regulations, initiatives, standards, and GVP.
- MedDRA and WHODrug Coding: Experience with MedDRA and WHODrug coding dictionaries and individual adverse event case report processing, triage, and medical review.
- Safety Databases: Experience with safety databases, including ARISg, ARGUS, or other safety database applications.
- Leadership and Mentoring: Proven leadership and mentoring skills, with experience guiding and mentoring team members.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, our passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
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