Associate Director, Global Drug Safety & Pharmacovigilance, Oncology – Early Phase Clinical Development
Genmab
full-time
Posted on:
Location Type: Hybrid
Location: Copenhagen • Denmark
Visit company websiteExplore more
Job Level
About the role
- Provide medical leadership and oversight of safety strategy and execution for assigned Genmab oncology assets across the product lifecycle.
- Ensure subject safety and welfare while driving compliant, scientifically rigorous safety decision-making, implementation and communications.
- Lead and oversee major safety-related activities for assigned products, including safety surveillance, signal detection, benefit-risk evaluation, and risk management throughout the product lifecycle.
- Chair and manage Genmab Safety Committees, ensure appropriate charters, effective meeting management, and timely documentation of decisions.
- Handle safety issues, propose risk mitigation strategies, and ensure effective implementation in collaboration with Medical team.
- Proactively engage internal multidisciplinary teams and serve as a medical safety interface with external experts, partners, CROs, and Regulatory Authorities as needed.
- Provide feedback and propose systemic solutions to strengthen safety processes, quality, and compliance.
- Perform and/or oversee medical review and assessment of adverse event data and individual case safety reports from multiple sources, including clinical trials and post-marketing activities.
- Prepare and/or provide medical oversight for regulatory-compliant safety documentation, including aggregate reports, safety summaries, risk management documents (e.g., DSURs, benefit–risk sections).
Requirements
- MD (or equivalent medical degree) required.
- 5+ years of experience in drug safety/pharmacovigilance across clinical development and post-marketing, preferably in oncology.
- Demonstrated experience leading medical safety activities for early phase clinical trials (Phase 1/2), including complex safety decision-making and cross-functional governance.
- Proven ability to guide and mentor team members, strong matrix leadership and stakeholder management skills.
- Experience with PV audit processes, including active participation in Regulatory Authority inspections, and working with FDA, EMA and other health authorities.
- Strong understanding of the global PV regulatory environment (regulations, initiatives, standards, GVP) and working knowledge of MedDRA and WHODrug.
- Experience overseeing individual case processing activities, including medical review, and contributing to signal evaluation.
- Experience with safety databases (e.g., Argus, or comparable systems) and clinical database.
- Excellent written and verbal communication skills, including authoring/reviewing safety sections of clinical/regulatory documents and presenting to internal and external governance bodies.
- Experience contributing to managing urgent safety issues and oncology protocol development.
Benefits
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
drug safetypharmacovigilancesafety surveillancesignal detectionbenefit-risk evaluationrisk managementmedical reviewadverse event data assessmentregulatory-compliant safety documentationclinical trial oversight
Soft skills
leadershipstakeholder managementmentoringcommunicationcross-functional governanceproblem-solvingteam collaborationdecision-makingmeeting managementfeedback provision
Certifications
MD