Genmab
Senior Director, Global Drug Safety & Pharmacovigilance Physician (Finance)
The Role
Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director, Global Drug Safety & Pharmacovigilance Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for his/her assigned Genmab products (investigational) throughout their lifecycle. This includes leading all major pre- and post-marketing safety related deliverables including signal, benefit-risk evaluation, and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with other Drug Safety (DS) staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
Responsibilities
• Perform medical review of Adverse Events reports for Genmab products.
• Perform ongoing surveillance of safety data for Genmab products from different sources.
• Ensure handling of safety issues and implementing risk mitigation activities.
• Perform medical review and provide input to different documents e.g. Trial Protocols and amendments, Clinical Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator's Brochures, Subject Informed Consent, Development Safety Update Reports, Integrated Safety Summaries, scientific articles, etc.
• Prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds.
• Responsible for establishment and management of external Data monitoring Committees (DMCs).
• Chair and manage Genmab Safety Committees for his assigned products.
• Conduct safety training of Genmab employees, CROs and Investigators.
• Member of CMTs and CDTs, contribute to multidisciplinary project groups and provide input to clinical development programs.
• Interact with safety and clinical CROs and perform sponsor oversight activities.
• Collaborate with external experts and partners.
• Contribute to multidisciplinary project groups.
• Ensure compliance with regulatory guidelines and internal procedures in order to be prepared for audits and inspections.
• Participate in audit and inspection activities as relevant.
• Lead the medical safety collaboration with partners if applicable.
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 and/or scientists.
Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.
At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee's role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.
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.
Genmab US, Inc. 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: https://www.genmab.com/privacy/us-applicants-privacy-notice/
Scam alert
Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.