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Janux Therapeutics · 1 day ago

Director, Pharmacovigilance

San Diego County, CA

Full-time

Onsite

Director/Executive

$230K/yr - $323K/yr

8+ years exp

Janux Therapeutics is seeking a Director of Pharmacovigilance to lead all safety-related activities across their clinical development programs. This role involves ensuring patient safety in clinical trials and compliance with global regulatory requirements, while also driving a culture of safety and continuous improvement within the organization.

BiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

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

Qualification

Pharmacovigilance strategiesGlobal PV regulationsSignal managementSafety data interpretationOncology experienceSafety databasesAnalytical skillsLeadershipCommunication skillsOrganizational skills