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 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.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES
- 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.
- MPH or pharmacoepidemiology training desirable.
- 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.
Skills Required
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or related field
- 8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry
- 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
What We Do
Janux Therapeutics is an innovative biopharmaceutical company developing next-generation therapeutics based on its proprietary Tumor Activated T Cell Engager (TRACTr) platform technology to better treat patients suffering from cancer. Janux’s initial focus is on developing a novel class of T cell engagers (TCEs), and its lead product candidates are designed to target clinically validated drug targets. While TCE therapeutics have displayed potent anti-tumor activity in hematological cancers, developing TCEs to treat solid tumors have faced challenges due to the limitations of prior TCE technologies, namely (i) overactivation of the immune system leading to cytokine release syndrome, (ii) on-target, healthy tissue toxicities, and (iii) poor pharmacokinetics leading to short half-life. Janux is using its TRACTr platform technology to engineer product candidates designed to overcome these limitations. Janux is developing a broad pipeline with lead programs targeting prostate-specific membrane antigen (PSMA), epidermal growth factor receptor (EGFR), and trophoblast cell surface antigen 2 (TROP2), with all of its programs currently in the IND-enabling or discovery stage.
