Job Description

Genmab seeks an Associate Director of Global Drug Safety & Pharmacovigilance Physician to provide medical oversight of product safety, including adverse event review, safety surveillance, and regulatory compliance. The role involves medical review of trial protocols, aggregate reporting, safety committee management, and cross-functional collaboration on clinical development programs.

Responsibilities

• Perform medical review of adverse event reports and ongoing safety surveillance from clinical trials
• Provide medical input to trial protocols, reports, informed consent documents, and regulatory deliverables
• Prepare aggregate safety reports and summaries in accordance with regulatory requirements
• Establish, manage, and chair Data Monitoring Committees and Genmab Safety Committees
• Collaborate with clinical teams, CROs, external partners, and regulatory stakeholders on safety matters

Requirements

• Medical degree (MD or equivalent) with clinical experience; oncology or hematology preferred
• 8+ years pharmacovigilance, drug safety, or clinical development experience in pharmaceutical/biotechnology
• Demonstrated expertise in adverse event medical review, safety surveillance, and benefit-risk assessment
• Experience providing medical safety input to protocols, Investigator's Brochures, informed consent, and regulatory submissions
• Strong knowledge of global pharmacovigilance requirements, Safety Committees, DMCs, and regulatory inspections
• Proficiency with FDA, EMA, PMDA, ICH requirements and good clinical practice standards
• Leadership capability and demonstrated ability to guide team members on complex safety matters

Compensation: $200,000-$300,000 base

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