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Summary:

The Senior Director, Safety & Pharmacovigilance will lead the development and execution of a global safety and pharmacovigilance strategy aligned with Vaxcyte's corporate objectives and regulatory requirements. This executive will ensure scientific excellence, regulatory alignment, and operational rigor. The successful candidate will drive proactive risk management, foster a culture of innovation, and represent Vaxcyte in senior leadership and external forums.

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 pharmacovigilance 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.

Reports to: Sr. Vice President, Clinical Development

Location: San Carlos, CA/Remote

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Hybrid (minimum of 2-3 days per week onsite)/Remote

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $285,000 - $333,000 (SF Bay Area). Salary ranges for non-California locations may vary.