Senior Director, Safety & Pharmacovigilance

Essential Functions

• Strategic Leadership & Vision
• Serve as the primary safety representative in senior leadership forums, governance bodies, and external engagements with regulatory authorities and partners.
• Champion a culture of safety, scientific integrity, and innovation across the organization. Anticipate and shape future strategic initiatives to ensure Vaxcyte remains at the forefront of safety science and regulatory compliance.
• Safety Evaluation & Risk Management
• Lead the identification, evaluation, and mitigation of safety risks across the product lifecycle, leveraging advanced analytics and real-world evidence.
• Oversee comprehensive safety signal detection, validation, and management, ensuring timely escalation and resolution of potential safety issues.
• Drive the development and execution of risk management plans, safety specifications, and benefit-risk assessments for regulatory submissions and ongoing clinical programs.
• Provide expert oversight for safety data review, including aggregate analyses, periodic safety reports (DSURs, PSURs), and responses to regulatory queries.
• Ensure robust safety surveillance through continuous monitoring of emerging safety data from clinical trials, post-marketing sources, literature, and external databases.
• Pharmacovigilance Operations & Compliance
• Oversee global PV systems and processes, including case processing, aggregate reporting, ensuring compliance with international regulations (FDA, EMA, PMDA, etc.).
• Lead safety-related elements of inspection readiness and manage responses to audits, regulatory inquiries, and corrective action plans.
• Develop and Maintain SOPs, safety governance frameworks to ensure operational excellence and regulatory compliance.
• Stay abreast of evolving global safety regulations, guidelines, and best practices, proactively updating Vaxcyte’s policies and procedures.
• Team Leadership & Development
• Build, lead, and mentor a high-performing team, fostering a culture of accountability, collaboration, and continuous learning.
• Provide strategic guidance, career development, and performance management for team members, ensuring the team’s growth and success.
• Drive organizational efficiency through effective resource management, outsourcing, and alliances.
• Cross-Functional & External Collaboration
• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality to ensure integrated safety oversight and seamless execution of safety strategies.
• Collaborate with external partners, CROs, and affiliates, managing PV vendors and pharmacovigivalence agreements, as needed to ensure consistent safety practices, reporting, and compliance across all programs.
• Represent Vaxcyte at external meetings with regulatory authorities, partners, and clinical investigators, advocating for patient safety and Vaxcyte’s scientific leadership.

Requirements

• Advanced degree (PhD, PharmD) in pharmacology, toxicology, epidemiology, pharmacy, life sciences, or a related field with 10-15 years of progressive experience in pharmacovigilance, drug safety, or clinical development in the biopharmaceutical industry, with at least 5 years in a leadership role. MS with 15+ years of experience is also eligible to apply. Other combinations of education and/or experience may be considered.
• Proven track record in global safety strategy, PV operations, and regulatory engagement, ideally within cell/gene therapy or advanced modalities.
• Expertise in safety signal detection, risk management, and benefit-risk assessment, including interactions with regulatory authorities.
• Strong analytical, strategic thinking, and communication skills; ability to influence at all levels of the organization.
• Demonstrated ability to lead cross-functional teams and drive organizational performance.
• Experience with safety databases (e.g., ARGUS, ARISg).
• Substantial experience specifically in vaccine safety science is required; experience spanning both development-stage and marketed vaccines strongly preferred.
• Demonstrated track record managing global regulatory PV submissions and health authority interactions (FDA, EMA, and at least one additional major health authority).
• Prior experience building or scaling a pharmacovigilance function preferred.

Core Competencies

• Expert-level knowledge of global PV regulations and guidelines (21 CFR 312/600, ICH E2A–E2F, GVP modules, WHO guidelines).
• Deep familiarity with Brighton Collaboration case definitions and AEFI methodology.
• Proficiency with pharmacovigilance safety databases (e.g., Veeva Vault Safety, Argus, ARISg) and signal detection tools.
• Strong understanding of epidemiological study design, including vaccine effectiveness and safety studies in real-world settings.
• Experience with VAERS, Vaccine Safety Datalink (VSD), and/or similar post-market vaccine surveillance systems a significant advantage.