Director, Pharmacovigilance

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Develop and execute pharmacovigilance strategies in alignment with Janux’s clinical and regulatory goals.
• Represent Janux in safety-related interactions with global health authorities (e.g., FDA, EMA, APAC).
• Lead the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies.
• Ensure safety is proactively integrated into clinical development and decision-making processes.
• Oversee the collection, evaluation, and reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials.
• Manage external PV vendors and ensure timely, high-quality execution of contracted activities.
• Maintain a central repository and program plan for all PV activities and deliverables.
• Ensure readiness and execution of safety procedures in response to emerging safety concerns.
• Author and review PV-related documents including DSURs, SMPs, RMPs, RSIs, and safety sections of clinical protocols and study reports.
• Ensure compliance with global PV regulations (FDA, EMA, APAC, ICH, GVP) and internal SOPs.
• Monitor and ensure adherence to PV agreements and safety data exchange agreements (SDEAs) with partners.
• Support internal audits and regulatory inspections; conduct root cause analyses and implement CAPAs as needed.
• Serve as the safety representative in cross-functional teams, including clinical, regulatory, and medical affairs.
• Educate internal teams on evolving safety regulations and best practices.
• Lead or contribute to internal safety review meetings, DSMBs, and safety advisory committees.
• Other duties as deemed necessary

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• Graduate-level degree in life sciences, RN, or equivalent health-related training; MD or PharmD preferred.
• 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.
• MPH or pharmacoepidemiology training desirable.
• Demonstrated ability to lead cross-functional safety initiatives and influence decision-making.
• Excellent communication, analytical, and organizational skills.
• Proficiency in safety databases (e.g., Argus, ARISg) and MedDRA coding.
• Ability to travel domestically and internationally as needed.