Director of Global Drug Safety
3 days ago
We are seeking a highly skilled and experienced Director of Global Drug Safety to join our team at Genmab. As a key member of our Drug Safety & Pharmacovigilance (GDS&PV) team, you will play a critical role in ensuring the safety of our products throughout their lifecycle.
Key Responsibilities- Lead major pre- and post-marketing safety-related activities, including signal, benefit-risk evaluation, and risk management activities.
- Collaborate with drug safety and cross-functional teams for safety assessment, ongoing surveillance, and related communication around assigned Genmab products.
- Oversee handling of safety issues and implement risk mitigation activities, proposing systemic solutions as needed.
- Provide inputs to different documents, such as trial protocols, amendments, and plans, clinical trial reports, eCRFs/CRFs, and TMFs, based on review.
- Prepare relevant documentation, including benefit/risk sections of aggregate reports and safety summaries, as per regulatory requirements.
- Manage internal and external forums, such as external Data Monitoring Committees (DMCs) and Genmab Safety Committees, for assigned products.
- Provide guidance, oversight, and training around safety to relevant stakeholders, including Genmab employees, CROs, and Investigators.
- Proactively engage with internal stakeholders and external stakeholders, including external experts and partners, around emerging landscapes and regulatory authorities around audits and inspections.
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations.
- MD required.
- Minimum requirement: 12+ years of experience in drug safety/pharmacovigilance in clinical development and post-marketing, preferably in oncology.
- Experience with PV audit process, active participation in Regulatory Authority Inspections, and working with the FDA and other regulatory authorities.
- Experience with global PV regulatory environment, regulations, initiatives, standards, GVP, MedDRA, and WHODrug coding dictionaries, and individual adverse event case report processing, triage, and medical review.
- Experience with safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems preferred.
- Experience guiding and mentoring team members.
- Proven performance in earlier role/comparable role.
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, resulting in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
We have formed 20+ strategic partnerships with biotechnology and pharmaceutical companies to help develop and deliver novel antibody therapies to patients. By 2030, our vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan.
We are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
Please see our privacy policy for handling your data in connection with your application on our website.
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