Vice President, Global Patient Safety Surveillance

Role Summary

Vice President of Safety Surveillance is a senior executive responsible for leadership, strategy, and execution of pharmacovigilance (PV) processes for development and post-market activities. The role focuses on risk management, aggregate reporting, signal detection, and benefit-risk assessment within a compliant pharmacovigilance system, ensuring inspection readiness and alignment with global regulations. You will build and lead a high-functioning PV team, collaborate with cross-functional groups, and provide scientific insights to maximize benefit-risk for patients.

Responsibilities

• Pharmacovigilance Aggregate Reporting
  • Develop and implement global PV aggregate reporting strategy in compliance with GCP, GVP, and GDocP.
  • Provide strategic direction to the GPS team and Development staff for DSUR, PSUR/PBRER, PADER reports; ensure accuracy, timeliness, and regulatory compliance.
  • Collaborate with Regulatory Medical Writing for writing consistency.
  • Oversee resourcing, budget, and management of PV CROs for aggregate reporting.
  • Lead development of controlled documentation to demonstrate PV oversight; ensure European compliance with QPPV as applicable.
  • Contribute to PV quality system development and maintenance; enable inspection readiness and act as SME for audits and inspections.
  • Foster safety culture and professional development; maintain current regulatory intelligence related to aggregate reporting and GDocP.
• Risk Management
  • Oversee PV risk management for GPS, including RMPs, aRMMs, and REMs across development and marketed products.
  • Contribute to development of Company Core Safety Information, Core Data Sheet, and local labels in collaboration with cross-functional stakeholders.
  • Build relationships across Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments to ensure integrated PV risk management.
• Benefit-Risk
  • Develop a cross-functional center of excellence for structured benefit-risk methodologies and tools for use throughout development.
  • Integrate structured benefit-risk processes into development teams to establish Company Core BR positions at defined milestones.
• Signal Detection
  • Develop strategy and processes for signal detection across development lifecycle compliant with post-market requirements.
  • Establish cross-functional assessment and adjudication mechanisms for signal management from identification to closure.
• Global Product Safety Leadership, Collaboration, Influence, Compliance, and Technical Expertise
  • Drive development of controlled documentation for GPS-sponsored processes; represent Safety in cross-functional settings.
  • Provide expert consultation on PV portions of regulatory reports and study documents (protocols, consent forms, investigator brochures, NDA modules, labeling strategies).
  • Build, mentor, and lead a high-performing global PV team.
  • Ensure clear communication of safety information to internal and external stakeholders.
  • Provide expertise in PV agreements (PVAs) and safety data exchange agreements (SDEA) with partners; partner with PV systems for fit-for-purpose PV systems.

Qualifications

• Required: Advanced degree in Medicine, Pharmacy, or related field (MD, PharmD, PhD preferred).
• Required: Minimum 20 years of experience in PV or related field in the pharmaceutical/biotechnology industry.
• Required: Minimum 15 years of people management experience; ability to lead in ambiguity.
• Required: Proven leadership in PV; strong regulatory interaction experience (FDA/EMA) at various scientific advisory levels.
• Required: In-depth knowledge of global PV regulations (ICH, GxP) and a track record of compliance.
• Required: Strong analytical, strategic thinking, problem-solving, and decision-making skills.
• Required: Excellent communication, collaboration, and team-management abilities; strong external representation.
• Required: Technical PV expertise; strong clinical leadership; high emotional intelligence; proven PV personnel development.

• Preferred: Experience with advanced safety data analytics and PV systems.
• Preferred: Ability to manage complex projects in a matrixed organization; regulatory interactions proficiency.
• Preferred: BLA/MAA experience; strong organizational and time management skills; excellent influence and teamwork.

Education

• Advanced degree in Medicine, Pharmacy, or a related field (MD, PharmD, PhD preferred).