Global PV & Drug Safety Physician Lead

Genmab; København; On-site; DKK 1,340,000 - 2,011,000; Full time

Benefits offered by this job

Health benefits

Dental & vision insurance

401(k) plan with match

Paid vacation and parental leave

Wellness programs

Job summary

Genmab is seeking an experienced physician-scientist to provide medical oversight of product safety, lead adverse event reviews and ongoing safety surveillance, and manage external Data Monitoring Committees. You will collaborate across functions, contribute to regulatory submissions, and ensure compliance with global pharmacovigilance standards.

The role requires a medical degree with oncology/hematology experience and 8+ years in pharmacovigilance or clinical development, with strong

Qualifications

• Medical degree (MD or equivalent) with relevant clinical experience; oncology or hematology experience preferred.
• 8+ years of experience in pharmacovigilance, drug safety, or clinical development within the pharmaceutical/biotechnology industry.
• Demonstrated experience in adverse event medical review, safety surveillance, signal evaluation, benefit–risk assessment, and aggregate safety reporting.
• Experience providing medical safety input to clinical trials and regulatory deliverables, including protocols, Investigator’s Brochures, informed consent documents, DSURs, clinical study reports, and integrated safety summaries.
• Strong knowledge of global pharmacovigilance and clinical development requirements, with experience supporting Safety Committees/DMCs, regulatory submissions, audits, and inspections.
• Strong medical judgment, leadership, and communication skills, with demonstrated ability to collaborate across functions, CROs, external partners, and regulatory stakeholders.
• Experience executing processes/projects in own area (e.g. guidance documents as per intl. regulations & reporting requirements; preparation of post-marketing spontaneous and clinical trial safety assessments; regulatory submissions; safety case processing; PV data systems; safety data base systems and the report generation)
• Experience working with FDA/EMA/PMDA/ICH requirements, good clinical practices, and pharmaceutical clinical development
• Experience guiding team members around complex issues

Responsibilities

• Perform medical review of Adverse Events reports for Genmab products.
• Perform ongoing surveillance of safety data from Genmab clinical trials.
• Ensure handling of safety issues.
• Perform medical review and provide input to e.g., Trial Protocols and amendments, Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator’s Brochures, Subject Informed Consent, Development Safety Update Reports, Integrated Safety Summaries, scientific articles, and medical reviews.
• Prepare aggregated reports and safety summaries in accordance with regulatory requirements.
• Responsible for the establishment and management of external Data Monitoring Committees (DMCs)
• Chair and manage Genmab Safety Committees
• Conduct training of Genmab employees, CROs and Investigators
• Member of Clinical Management Teams (CMTs), Compound Development Teams (CDT) and Compound Strategy Teams (CST) and contribute to multidisciplinary project groups and provide input to clinical development programs.
• Interact with safety and clinical CROs and perform sponsor oversight activities.
• Collaborate with external experts and partners.
• Contribute to multidisciplinary project groups.
• Ensure compliance with regulatory guidelines and internal procedures in order to be prepared for audits and inspections.
• Participate in audit and inspection activities as relevant

Skills

Pharmacovigilance experience

Clinical development experience

Adverse event review

DMC oversight

Cross-functional collaboration

Regulatory submissions & audits

Leadership & communication

Education

MD or equivalent

Tools

PV data systems

Job description

Genmab is seeking an experienced physician-scientist to provide medical oversight of product safety, lead adverse event reviews and ongoing safety surveillance, and manage external Data Monitoring Committees. You will collaborate across functions, contribute to regulatory submissions, and ensure compliance with global pharmacovigilance standards.

The role requires a medical degree with oncology/hematology experience and 8+ years in pharmacovigilance or clinical development, with strong