Associate Director, Global Drug Safety and Pharmacovigilance Scientist

About the position The Associate Director, Global Drug Safety and Pharmacovigilance Scientist will be responsible for performing safety review of Adverse Event reports for Genmab products. Supporting high-priority, complex oncology development programs, including fast-tracked and pivotal programs such as Rinatabart sesutecan (Rina-S / GEN1184), from first-in-human through late-stage development and post-marketing. Providing strategic safety input for protocol amendments, risk mitigation strategies, and study design decisions based on emerging safety data from pivotal and registrational studies. Supporting Health Authority interactions related to safety signals, clinical holds, risk mitigation measures, and responses to regulatory questions for advanced-stage oncology programs. Leading or significantly contributing to safety strategy and documentation supporting pivotal development milestones and regulatory submissions. Playing an active role in cross-functional safety governance forums (e.g., Safety Committees, Risk Management Working Groups), including preparation and presentation of integrated safety analyses for senior stakeholders. Representing Global Drug Safety as a core member of Clinical Management Teams (CMTs) for complex oncology programs, providing expert safety guidance to clinical, regulatory, and operational stakeholders. Providing sponsor oversight of global CROs supporting pivotal oncology studies, ensuring quality, timeliness, and regulatory compliance of safety deliverables. Performing ongoing surveillance (including signal detection/evaluation) of Genmab clinical trials and post marketing safety data. Providing safety review and input to various documents including, but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs as well as contributing to the development of other documentation such as Investigator’s Brochures, and Subject Informed Consent. Contributing to HA requests and reviewing key submission documents. Contributing to safety-related documents for Genmab products throughout the product lifecycle from FIH to post-marketing, including monthly safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g. DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc requests for safety information internally and externally. Contributing to the planning and conduct of Safety Committee activities and DMC’s. Conducting safety training of Genmab employees, CROs, Investigators and other relevant site personnel as necessary. Contributing to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products. Contributing to the development and optimization of new tools and processes. Interacting with safety and clinical CROs, performing sponsor oversight activities for safety related tasks, process invoices, and ensuring regulatory compliance (including regulatory reporting requirements) for assigned products. Supporting review of Safety Data Exchange Agreements with partners as required. Performing ongoing surveillance of new and updated regulations/guidelines and assessing the impact on drug safety processes at Genmab. Ensuring compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections. Participating in audit and inspection activities as required.

Responsibilities

• Performing safety review of Adverse Event reports for Genmab products.
• Supporting high-priority, complex oncology development programs, including fast-tracked and pivotal programs such as Rinatabart sesutecan (Rina-S / GEN1184), from first-in-human through late-stage development and post-marketing.
• Providing strategic safety input for protocol amendments, risk mitigation strategies, and study design decisions based on emerging safety data from pivotal and registrational studies.
• Supporting Health Authority interactions related to safety signals, clinical holds, risk mitigation measures, and responses to regulatory questions for advanced-stage oncology programs.
• Leading or significantly contributing to safety strategy and documentation supporting pivotal development milestones and regulatory submissions.
• Playing an active role in cross-functional safety governance forums (e.g., Safety Committees, Risk Management Working Groups), including preparation and presentation of integrated safety analyses for senior stakeholders.
• Representing Global Drug Safety as a core member of Clinical Management Teams (CMTs) for complex oncology programs, providing expert safety guidance to clinical, regulatory, and operational stakeholders.
• Providing sponsor oversight of global CROs supporting pivotal oncology studies, ensuring quality, timeliness, and regulatory compliance of safety deliverables.
• Performing ongoing surveillance (including signal detection/evaluation) of Genmab clinical trials and post marketing safety data.
• Providing safety review and input to various documents including, but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs as well as contributing to the development of other documentation such as Investigator’s Brochures, and Subject Informed Consent.
• Contributing to HA requests and reviewing key submission documents.
• Contributing to safety-related documents for Genmab products throughout the product lifecycle from FIH to post-marketing, including monthly safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g. DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc requests for safety information internally and externally.
• Contributing to the planning and conduct of Safety Committee activities and DMC’s.
• Conducting safety training of Genmab employees, CROs, Investigators and other relevant site personnel as necessary.
• Contributing to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products.
• Contributing to the development and optimization of new tools and processes.
• Interacting with safety and clinical CROs, performing sponsor oversight activities for safety related tasks, process invoices, and ensuring regulatory compliance (including regulatory reporting requirements) for assigned products.
• Supporting review of Safety Data Exchange Agreements with partners as required.
• Performing ongoing surveillance of new and updated regulations/guidelines and assessing the impact on drug safety processes at Genmab.
• Ensuring compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections.
• Participating in audit and inspection activities as required.

Requirements

• Bachelor’s degree (or foreign equivalent) in Pharmacy, Chemistry, or a related natural sciences field
• At least 7 years (84 months) of experience with drug safety and pharmacovigilance in the pharmaceutical industry for products in clinical trial and postmarketing environments.
• At least 7 years (84 months) of progressive post-baccalaureate experience with all of the following: (a) first human trials; (b) overseeing multiple trials with safety inputs at the global level; (c) collaborating with cross-functional teams to continuously improve the efficiency of quality control processes, contributing to audit readiness and ensuring alignment with both client expectations and regulatory requirements; (d) performing ongoing surveillance (including signal detection and evaluation) of safety data; (e) ensuring compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections; (f) international experience with internal and external stakeholders; and (g) Argus Safety Database.

Nice-to-haves

• Experience working in a fast-growing, dynamic company (or a strong desire to)

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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