Executive Director, Pharmacovigilance (PV)

Duties and Responsibilities

• Late-Phase Global Pharmacovigilance Operations
  • Lead and execute all PV activities for Phase 3 and registrational biologics programs
  • Ensure 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
  • MedDRA coding review and benefit-risk assessment updates
• Manage and optimize safety data receipt, processing, and reporting workflows
  • 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
• Aggregate Safety Reporting & Regulatory Submissions
  • Author and/or oversee the preparation of Integrated Safety Summaries (ISS) and Integrated Summaries of Efficacy (ISE) for BLA and MAA submissions
  • Ensure scientific rigor, internal consistency, and full alignment with regulatory expectations
• Oversaw end-to-end safety labeling strategy for biologics
  • Ensure 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
  • 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)
  • Respond to health authority questions and requests for safety information during regulatory review processes
• Safety Surveillance & Pharmacoepidemiology
  • Design and implement systematic pharmacovigilance surveillance programs
  • 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
  • Interpret safety trends across populations and study designs
• Support post-marketing commitments and Phase 4 safety studies
  • Protocol development and safety monitoring plan creation

Education/Experience/Skills

• 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
• 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
• Demonstrated leadership and cross-functional collaboration is crucial