The RoleThe Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned Genmab products throughout their lifecycle management. As Director, you are expected to effectively engage cross-functionally at all levels of the organization, as well as with external stakeholders, including Regulatory Authorities, as applicable. This is an individual contributor role at the Director level, with no direct people management responsibilities. The role reports to the Vice President, MD Team Lead.
You will work together with other Drug Safety 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 supporting the Team Lead. A strong ability to adapt and perform in a dynamic, fast-paced environment is essential to meeting both corporate and patient needs.
This globally focused role involves engagement with a broad range of stakeholders, including regulatory authorities, Data Monitoring Committees, and colleagues across Genmab’s international sites. As Director, GDS & PV Physician, you will be a key member of a highly skilled global team and act as an ambassador for GDS & PV across the organization, including leading education and training on PV principles. A critical aspect of this role is mentoring and developing junior colleagues to enable their success and growth.
Responsibilities- Lead all major pre- and post-marketing safety-related activities including signal, benefit-risk evaluation and risk management activities for own area
- Effectively collaborate with drug safety and cross-functional teams for safety assessment (e.g. review of AEs and scientific literature; safety reports), ongoing surveillance, and related communication around assigned Genmab products
- Oversee handling safety issues and implementing risk mitigation activities, and propose systemic solutions
- Provide inputs to different documents (e.g. trial protocols, amendments and plans; clinical trial reports; eCRFs/CRFs;TMFs) based on review
- Prepare relevant documentation (e.g. benefit/risk sections of aggregate reports; safety summaries such as submission modules 2.7.4, clinical overview, etc..) as per regulatory requirements
- Manage internal & external forums (e.g. external Data monitoring Committees (DMCs); Genmab Safety Committees) for assigned products
- Provide guidance, oversight, and training around safety to relevant stakeholders (e.g. Genmab employees, CROs, Investigators)
- Proactively engage with internal stakeholders (e.g. multidisciplinary project groups) and external stakeholders (e.g. external experts and partners around emerging landscape; regulatory authorities around audits and inspections)
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations
Requirements- MD required
- Minimum requirement: 12+ years’ experience in drug safety/pharmacovigilance in clinical development and post-marketing preferably in oncology
- Experience with BLA and/or NDA submission, PV audit process with 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
For US based candidates, the proposed salary band for this position is as follows:
$235,840.00---$353,760.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
