Senior Manager, Pharmacovigilance

United States·San DiegoFull-Timesenior

OtherManagerHealthcare

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OtherManagerHealthcare

The Senior Manager, Pharmacovigilance will be responsible for the execution and oversight of pharmacovigilance activities for Janux programs. This individual will ensure compliance with global safety regulations and support the identification, evaluation and communication of safety information across all Janux programs. This role combines strategic oversight with hands-on execution, ensuring integration of safety into drug development. The Senior Manager will also serve as a key liaison with internal and external stakeholders.

Manage end-to-end pharmacovigilance activities for oncology clinical trials, including case intake, processing, medical review and reporting of Individual Case Safety Reports (ICSRs).

Lead the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies.

Manage external PV vendors and ensure timely, high-quality execution of contracted activities

Support preparation and submission of Development Safety Update Reports (DSURs), periodic safety reports, and safety listings.

Support ongoing safety surveillance, including aggregate data review, signal detection, and risk evaluation activities.

Maintain Reference Safety Information (RSI) and contribute to benefit-risk assessment across development programs.

Contribute to safety sections of clinical study protocol, informed consent forms (ICFs), investigator brochures (IBS) and clinical study reports (CSRs).

Support IND/CTA submissions, amendments and regulatory interactions related to safety.

Develop, implement and maintain pharmacovigilance SOPs, work instructions and training materials.

Support internal audits and regulatory inspections; conduct root cause analyses and implement CAPAs as needed.

Ensure PV systems and databases are compliant and inspection-ready.

Provide functional leadership and subject-matter expertise for pharmacovigilance within cross-functional teams.

Other duties as deemed necessary.

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field required.

8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry, including proven leadership roles.

Strong knowledge of global PV regulations (FDA, EMA, APAC, ICH, GVP).

Experience in signal management, safety data interpretation, and regulatory reporting.

Oncology and autoimmune experience will be prioritized in this role.

Demonstrated experience managing CROs and external vendors.