Vaxcyte
Senior Director, Safety & Pharmacovigilance
San Carlos, California, United States · Director
Sponsorship not specified$285k-$333kDetected 4 days ago
Product ManagementPerformance ManagementClinical TrialsFDA RegulatoryCRISPRPharmacovigilanceExperimental DesignLeadershipCommunicationCollaborationRegulatory Affairs
About the role
- Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
- Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
- Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
Responsibilities
- 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.
- The successful candidate will drive proactive risk management, foster a culture of innovation, and represent Vaxcyte in senior leadership and external forums.
- Serve as the primary safety representative in senior leadership forums, governance bodies, and external engagements with regulatory authorities and partners.
- Lead the identification, evaluation, and mitigation of safety risks across the product lifecycle, leveraging advanced analytics and real-world evidence.
Requirements
- 8+ years of progressively increasing leadership responsibility within Safety Science or related field required.
- Proven track record in global safety strategy, PV operations, and regulatory engagement, ideally within cell/gene therapy or advanced modalities.
- ability to influence at all levels of the organization.
- Experience with safety databases (e.g., ARGUS, ARISg).
- Expert-level knowledge of global PV regulations and guidelines (21 CFR 312/600, ICH E2A-E2F, GVP modules, WHO guidelines).
- 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.
Nice to have
- RN, PharmD, PA or NP, or equivalent preferred with a minimum of 10 years of experience
- experience spanning both development-stage and marketed vaccines strongly preferred.
- Substantial experience specifically in vaccine safety science is required
Compensation
- $285,000 - $333,000 (SF Bay Area). Salary ranges for non-California locations may vary.
- The compensation package will be competitive and includes comprehensive benefits and an equity component.
Benefits
- Drive the development and execution of risk management plans, safety specifications, and benefit-risk assessments for regulatory submissions and ongoing clinical programs.
Company info
- Join our Mission to Protect Humankind!
Equal opportunity
- We are an equal opportunity employer.
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This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.