The Role:This role provides medical oversight of product safety, including adverse event review, ongoing safety surveillance, and management of emerging safety issues. Responsibilities include safety input to clinical and regulatory deliverables, aggregate reporting, safety committee oversight, cross-functional collaboration, and ensuring regulatory compliance and inspection readiness.
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
Requirements:
- 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
For US based candidates, the proposed salary band for this position is as follows:
$200,000.00---$300,000.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 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 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
