Director, Global Drug Safety & Pharmacovigilance Physician

About the Role

The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical position contributing to the global safety strategy and overall safety profile for assigned Genmab products throughout their lifecycle management. This individual contributor role at the Director level reports to the Vice President, MD Team Lead, and involves no direct people management responsibilities.

Responsibilities

• Lead all major pre- and post-marketing safety-related activities, including signal detection, benefit-risk evaluation, and risk management.
• Collaborate with drug safety and cross-functional teams on safety assessments, surveillance, and communication for assigned products.
• Oversee handling of safety issues, implement risk mitigation activities, and propose systemic solutions.
• Provide input to documents such as trial protocols, amendments, clinical trial reports, eCRFs/CRFs, and TMFs.
• Prepare regulatory documentation, including benefit/risk sections of aggregate reports and safety summaries (e.g., submission modules 2.7.4, clinical overview).
• Manage internal and external forums, such as Data Monitoring Committees (DMCs) and Genmab Safety Committees.
• Provide guidance, oversight, and training on safety to stakeholders, including Genmab employees, CROs, and Investigators.
• Engage proactively with internal and external stakeholders, including regulatory authorities, on emerging safety aspects and PV processes.
• Train and mentor junior colleagues on safety aspects, PV processes, technologies, and regulations.

Requirements

• MD required.
• Minimum 12+ years’ experience in drug safety/pharmacovigilance in clinical development and post-marketing, preferably in oncology.
• Experience with BLA and/or NDA submissions, PV audit processes, and participation in Regulatory Authority Inspections (e.g., FDA).
• Knowledge of global PV regulatory environment (GVP), MedDRA, WHO Drug coding dictionaries, and adverse event case processing.
• Experience with safety databases (e.g., ARISg, ARGUS) and electronic data capture systems preferred.
• Proven ability to guide and mentor team members.

Pay

For US-based candidates, the proposed salary band for this position is $235,840.00—$353,760.00. The actual offer will consider factors such as skills, qualifications, experience, and location. Additional compensation may include discretionary bonuses and long-term incentives.

Benefits

• 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 backup care, family support programs, financial wellness tools, and emotional well-being support.
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account.

About Genmab

Genmab is an international biotechnology company dedicated to improving lives through innovative antibody therapeutics. With 25 years of expertise, Genmab develops next-generation antibody technologies and a proprietary pipeline, including bispecific T-cell engagers, antibody-drug conjugates, and immune checkpoint modulators. By 2030, Genmab aims to transform lives with Knock-Your-Socks-Off (KYSO®) antibody medicines. Headquartered in Copenhagen, Denmark, Genmab has a global presence across North America, Europe, and Asia Pacific.