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.
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
Schedule:
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Monday to Friday
Work authorization:
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United States (Required)
Additional Compensation:
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Annual targeted bonus %
Work Location:
Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required.
EQUAL OPPORTUNITY EMPLOYER:
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.