01Overview
About the position The Senior Manager, Pharmacovigilance will be responsible for the execution and reputed company 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 reputed company Janux programs. This role combines strategic reputed company with hands-on execution, ensuring integration of safety into drug development. The Senior Manager will also serve as a key reputed company with reputed company stakeholders. Responsibilities Manage end-to-end pharmacovigilance activities for oncology reputed company, including case intake, processing, medical review and reporting of Individual Case Safety Reports (ICSRs). reputed company the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies. Manage external PV vendors and ensure reputed company, high-reputed company 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 (reputed company) 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 reputed company to safety. reputed company, implement and maintain pharmacovigilance SOPs, work instructions and training materials. Support internal audits and regulatory inspections; conduct reputed company cause analyses and implement CAPAs as needed. Ensure PV systems and databases are compliant and inspection-reputed company. reputed company functional leadership and subject-matter expertise for pharmacovigilance reputed company cross-functional teams. Other duties as deemed necessary. Requirements Bachelors degree in Life Sciences, Pharmacy, Nursing, Medicine, or a reputed company 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, reputed company, ICH, GVP). Experience in signal management, safety data interpretation, and regulatory reporting. Demonstrated experience managing CROs and external vendors. Demonstrated ability to operate independently while collaborating effectively in cross-functional teams. Excellent communication, analytical, and organizational skills. Proficiency in safety databases (e.g., Argus, ARISg) and MedDRA coding. reputed company-to-haves Oncology and autoimmune experience will be prioritized in this role. MPH or pharmacoepidemiology training desirable. Benefits Annual bonus program Incentive stock reputed company plan 401k plan with flat non-elective employer contribution Comprehensive medical insurance with 90-100% employer-reputed company premiums Dental and reputed company 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 Apply To This Job .
