Executive Director, Pharmacovigilance (PV)

• Lead and execute all PV activities for Phase 3 and registrational biologics programs, ensuring full compliance with ICH E2A, E2B, E2C, E2D, and E2E guidelines, as well as FDA, EMA, and other applicable regional requirements.
• Oversee global signal detection, evaluation, and management activities, including Medical Dictionary for Regulatory Activities (MedDRA) coding review and benefit-risk assessment updates.
• Manage and optimize safety data receipt, processing, and reporting workflows, including collaboration with CROs, data management teams, and clinical operations.
• Serve as the subject-matter expert and primary PV point of contact for cross-functional clinical teams, regulatory affairs, and medical affairs.
• Maintain and enforce the company's global safety database and adverse event reporting infrastructure, including oversight of vendor relationships.

• Author and/or oversee the preparation of Integrated Safety Summaries (ISS) and Integrated Summaries of Efficacy (ISE) for BLA and MAA submissions (member of the submission team), ensuring scientific rigor, internal consistency, and full alignment with regulatory expectations (21 CFR 314.50, Module 2.7.4, ICH E3, ICH M4E).
• Oversaw end-to-end safety labeling strategy for biologics, ensuring compliance with FDA, EMA, and other global regulatory requirements for products with boxed warnings, REMS, restricted access programs, and other post-marketing risk mitigation obligations.
• Lead the development of Clinical Study Report (CSR) safety sections for Phase 2 and Phase 3 studies, including narrative writing, adverse event tabulations, and laboratory data analyses.
• Prepare and manage Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs) on global schedules.
• Prepare Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), including strategy development and execution.
• Respond to health authority questions and requests for safety information during regulatory review processes (e.g., Complete Response Letters, Day 120/180 questions).

• Design and implement systematic pharmacovigilance surveillance programs, including benefit-risk monitoring frameworks and safety monitoring plans for clinical trials.
• Conduct and document ongoing signal detection activities; prepare signal assessment reports and escalate findings to the Safety Monitoring Committee and/or Data Safety Monitoring Board (DSMB) as appropriate.
• Collaborate with clinical pharmacology and biostatistics teams to interpret safety trends across populations and study designs.
• Support post-marketing commitments and Phase 4 safety studies, including protocol development and safety monitoring plan creation.

• Partner with Clinical and Regulatory Affairs to define global filing strategy and PV regulatory timelines; represent the PV function in Health Authority meetings and advisory committee preparations.
• Collaborate with Medical Affairs and Commercial teams on labeling updates, healthcare professional communications, and post-approval safety activities.
• Build, mentor, and manage a small PV team (or oversee contract resources) as the company scales; establish and maintain SOPs, work instructions, and quality standards.
• Evaluate, select, and manage CRO/vendor partnerships for pharmacovigilance services; conduct oversight audits and ensure GVP compliance.
• Represent PV on the Clinical Development Team (CDT) and participate in Program Team leadership meetings.

• Doctor of Medicine (MD) degree from an accredited institution is required.
• 12+ years of progressive pharmaceutical/biotech industry pharmacovigilance experience, with at least 5 years in a senior role with direct accountability for late-phase global biologics PV programs.
• Demonstrated hands-on authorship of Integrated Safety Summaries (ISS) submitted in at least one BLA or MAA; experience with multiple submissions strongly preferred.
• Extensive experience authoring CSR safety sections, DSURs, and PSURs/PBRERs for biologic compounds in global development.
• Deep command of ICH guidelines (E2A–E2E, E6, E8, M4E), FDA/CDER and EMA/EMA GVP Module requirements, and regional pharmacovigilance regulations (EU, US, Japan, and other ICH regions).
• Extensive experience with signal detection methodologies, benefit-risk assessment frameworks, and safety narrative writing.
• Proven track record managing CRO/vendor PV relationships and safety database oversight (Argus, ARISg, or equivalent).
• Experience in small biotech or start-up environments is desired; comfortable operating with limited infrastructure and high personal accountability.
• Experience with BLA or MAA approval for a biologic; post-approval PV experience a plus.
• Familiarity with rare disease, orphan drug, or first-in-class biologic programs.
• Experience presenting to Health Authorities (FDA, EMA) and participation in Advisory Committee proceedings.
• Familiarity with REMS design and implementation or EU RMP preparation.
• Knowledge of pharmacoepidemiology methodologies and real-world evidence applications in safety assessment.
• Exceptional scientific and medical writing ability; proven capacity to synthesize complex safety data into clear, structured regulatory documents under tight timelines.
• Strong analytical and critical thinking skills; ability to independently evaluate complex safety signals and formulate evidence-based recommendations.
• High scientific credibility with the ability to engage and challenge clinical, statistical, and regulatory colleagues at a peer level.
• Excellent project management skills; able to manage multiple competing priorities without sacrificing quality.
• Demonstrated leadership and cross-functional collaboration is crucial.

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