Director, Global Drug Safety & Pharmacovigilance Physician
$235,840 - $353,760 per year
ApplyDirector, Global Drug Safety & Pharmacovigilance Physician
Posted 4 days ago
SENIORITY
Manager
SALARY
$235,840 - $353,760 per year
About the role
- 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
- 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
- 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
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