Senior Director, Global Drug Safety and Pharmacovigilance
2 weeks ago
Genmab is seeking a highly skilled Senior Director, Global Drug Safety and Pharmacovigilance to join our team. As a key member of our organization, you will be responsible for leading the global safety strategy and overall safety profile for assigned Genmab products throughout their lifecycle.
Key Responsibilities
- Develop and implement global safety strategies to ensure the safe use of Genmab products
- Lead cross-functional teams to identify and mitigate safety risks
- Collaborate with regulatory authorities to ensure compliance with global regulations
- Develop and maintain safety databases and reports
- Provide medical expertise to support product development and commercialization
Requirements
• MD required; clinical research and/or fellowship training in oncology/hematology, pharmacology or other relevant specialty is a plus
• Minimum 10 years Drug Safety/Pharmacovigilance experience plus 2 years clinical development experience; other relevant experience may be considered
• Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP)
• Exposure to working relationship with the FDA and other regulatory authorities is preferred
• Strong knowledge of individual adverse event case report processing, triage and medical review
• Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems is preferred
• MedDRA trained and working knowledge of MedDRA and WHODrug coding dictionaries
• Working experience with PV audit process with active participation in Regulatory Authority Inspections
• Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position
• Excellent knowledge of drug development process
• Requires a high level of initiative and independence
• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
• Computer literacy with proficiency in Microsoft Excel, PowerPoint, and Word
• Experience leading a team of physicians
Genmab is an equal opportunities employer and welcomes applications from all qualified candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
About Genmab
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, its 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. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's 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.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we 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. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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