Senior Director, Safety & Pharmacovigilance

Job title: Senior Director, Safety & Pharmacovigilance

About the Role The Senior Director, Safety & Pharmacovigilance will lead the global safety and pharmacovigilance strategy aligned with Vaxcyte’s objectives and regulatory requirements. This executive will ensure scientific excellence, regulatory alignment, and operational rigor, driving proactive risk management and representing Vaxcyte in senior leadership and external forums.

What You'll Do

• 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 keep Vaxcyte at the forefront of safety science and regulatory compliance.
• Lead identification, evaluation, and mitigation of safety risks across the product lifecycle, leveraging advanced analytics and real-world evidence.
• Oversee safety signal detection, validation, and management, ensuring timely escalation and resolution of potential safety issues.
• Drive development and execution of risk management plans, safety specifications, and benefit-risk assessments for regulatory submissions and ongoing clinical programs.
• Provide oversight for safety data reviews, including aggregate analyses, DSURs/PSURs, and responses to regulatory queries.
• Ensure robust safety surveillance through continuous monitoring of emerging safety data from trials, post-marketing sources, literature, and external databases.
• Oversee global PV systems and processes, including case processing, aggregate reporting, ensuring compliance with international regulations.
• Lead safety-related elements of inspection readiness and manage responses to audits and regulatory inquiries.
• Develop and maintain SOPs and safety governance frameworks to ensure operational excellence and regulatory compliance.
• Stay abreast of evolving global safety regulations, guidelines, and best practices, proactively updating policies and procedures.
• Build, lead, and mentor a high-performing team, fostering accountability, collaboration, and continuous learning.
• Drive organizational efficiency through effective resource management, outsourcing, and alliances.
• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality for integrated safety oversight and seamless execution of safety strategies.
• Collaborate with external partners, CROs, and affiliates, managing PV vendors and pharmacovigilance agreements to ensure consistent safety practices and compliance across programs.
• Represent Vaxcyte at external meetings with regulatory authorities, partners, and clinical investigators, advocating for patient safety and scientific leadership.

What We're Looking For

• Advanced degree in pharmacology, toxicology, epidemiology, pharmacy, life sciences, or related field with 10-15 years of progressive experience in pharmacovigilance, drug safety, or clinical development in biopharma, with at least 5 years in a leadership role. MS with 15+ years of experience is also eligible.
• 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.
• Demonstrated ability to lead cross-functional teams and drive organizational performance.
• Experience with safety databases.
• Substantial experience in vaccine safety science; experience with both development-stage and marketed vaccines strongly preferred.
• Track record managing global regulatory PV submissions and health authority interactions.
• Prior experience building or scaling a pharmacovigilance function is preferred.

Nice to Have

• Prior experience building or scaling a pharmacovigilance function.
• Significant vaccine safety science experience, including both development-stage and marketed vaccines.
• Experience with global regulatory PV submissions and health authority interactions.
• Experience working with PV databases.