Senior Manager, Pharmacovigilance

The Senior Manager, Pharmacovigilance will be responsible for the execution and oversight of pharmacovigilance activities for Janux programs, ensuring compliance with global safety regulations and supporting the identification, evaluation and communication of safety information across all Janux programs.

Requirements

• Manage end-to-end pharmacovigilance activities for oncology clinical trials
• Develop and implement 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

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with flat non-elective employer contribution
• Comprehensive medical insurance with 90-100% employer-paid premiums
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
• Unlimited PTO
• Generous holiday schedule; includes summer and winter company shutdown
• Relocation assistance