Senior Manager, Pharmacovigilance

Job description

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. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: - 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 de...