Janux Therapeutics

Senior Manager, Pharmacovigilance

Janux Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California • United States

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Salary

💰 $165,000 - $185,000 per year

Job Level

Senior

About the role

  • 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.

Requirements

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
pharmacovigilancecase intakemedical reviewrisk management planssignal detectionsafety data interpretationregulatory reportingsafety management plansbenefit-risk assessmentroot cause analysis
Soft Skills
leadershipcollaborationcommunicationanalytical skillsorganizational skillsindependence
Certifications
Bachelor’s degree in Life SciencesMPHpharmacoepidemiology training