Associate Director, Global Drug Safety & Pharmacovigilance Physician

About the position At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Genmab US, Inc. Associate Director, Global Drug Safety & Pharmacovigilance Physician Location: Plainsboro, NJ Job Description Serve as the safety expert accountable for the global safety strategy and overall safety profile for assigned Genmab products (investigational) throughout their lifecycle, including leading all major pre- and post-marketing safety related deliverables, including signal, benefit-risk evaluation and risk management activities. Interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. Work together with other Drug Safety (DS) staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. Perform medical review of Adverse Events reports for Genmab products. Perform ongoing surveillance of safety data for Genmab products from different sources. Ensure handling of safety issues and implementing risk mitigation activities. Perform medical review and provide input to different documents e.g. Trial Protocols and amendments, Clinical Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator’s Brochures, Subject Informed Consent, Development Safety Update Reports, Integrated Safety Summaries, scientific articles, etc. Prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds. Responsible for establishment and management of external Data monitoring Committees (DMCs). Position allows working from home within commuting distance of worksite location. Annual salary between: $227,490-$280,320.

Responsibilities

• Serve as the safety expert accountable for the global safety strategy and overall safety profile for assigned Genmab products (investigational) throughout their lifecycle, including leading all major pre- and post-marketing safety related deliverables, including signal, benefit-risk evaluation and risk management activities.
• Interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities.
• Work together with other Drug Safety (DS) staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders.
• Perform medical review of Adverse Events reports for Genmab products.
• Perform ongoing surveillance of safety data for Genmab products from different sources.
• Ensure handling of safety issues and implementing risk mitigation activities.
• Perform medical review and provide input to different documents e.g. Trial Protocols and amendments, Clinical Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator’s Brochures, Subject Informed Consent, Development Safety Update Reports, Integrated Safety Summaries, scientific articles, etc.
• Prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds.
• Responsible for establishment and management of external Data monitoring Committees (DMCs).

Requirements

• The qualified candidate must have a Doctor of Medicine degree or foreign equivalent degree.
• The qualified candidate must have at least 10 years (120 months) of Drug Safety/Pharmacovigilance and clinical development experience.
• The qualified candidate must have at least 10 years (120 months) of experience with all of the following: (a) global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP); (b) working with the FDA and other regulatory authorities; (c) individual adverse event case report processing, triage and medical review; (d) safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems; (e) MedDRA, and MedDRA and WHODrug coding dictionaries; (f) PV audit process with active participation in Regulatory Authority Inspections; (g) drug development process; (h) utilizing the following technologies: Microsoft Excel, PowerPoint and Word.
• Position allows working from home within commuting distance of worksite location.
• All experience may be gained concurrently.

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 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

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