Associate Director - Safety and Pharmacovigilance

4w4 weeks ago

Kyverna

Emeryville, US · Full-time · $170,000 – $200,000

About this role

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The Associate Director of Safety and Pharmacovigilance will be an integral part of the Global Patient Safety and PV team, supporting both PV operations and safety science/risk management activities for assigned investigational and marketed products.

Day-to-day responsibilities include ensuring adherence to report timelines, managing safety vendor relationships, and leading signal detection and management activities. The role involves drafting safety sections of investigator brochures, aggregate reports, and Risk Management Plans, as well as supporting global regulatory submissions.

This position reports to the Senior Vice President, Head of Safety, and collaborates closely with cross-functional safety teams and the safety physician. The individual will serve as a resource for inspections and audits, and present quality and performance findings to the Head of PV and relevant stakeholders.

This role offers the opportunity to work at the forefront of cell therapy innovation, contributing to high-quality scientific safety assessment in a hybrid or remote environment. The successful candidate will help redefine what’s possible for autoimmune disease treatment while developing an expert understanding of the latest safety regulations and product profiles.

Requirements

Minimum 8 years of experience working within Pharmacovigilance, with experience in both PV operations and clinical safety/safety science (e.g., signal detection, risk management, regulatory responses)
Advanced knowledge of safety databases (i.e., Argus), MedDRA coding, signal detection, aggregate reports, and RMPs
Experience with neurology or autoimmune diseases preferred
Bachelor’s Degree in a scientific, life sciences, or medical field; advanced degree in life science, epidemiology, or certification/licensure in Nursing or pharmacology preferred
Ability to develop and maintain an expert understanding of the latest safety regulations, technology, and safety profile of assigned products
Understanding of how AI can be applied in pharmacovigilance contexts

Responsibilities

Ensure adherence to report timelines and communicate issues to management as appropriate
Manage and support the relationship with safety vendors to ensure effectiveness, quality and compliance of all outsourced activities
Lead oversight of quality and key performance indicators for case processing and aggregate reports, presenting findings to Head of PV and cross-functional stakeholders
Serve as a resource for inspections and audits
Lead signal detection and management activities, including literature search, data analyses, and preparation of safety data for cross-functional safety team meetings
Lead the drafting of safety sections of IB, aggregate reports (e.g., PADERs, PSURs, PBRERs, DSURs), and Risk Management Plans
Support and contribute to global regulatory submissions, including drafting responses to Health Authority requests and authoring review packages

Benefits

Hybrid work model based in Emeryville, CA, or fully remote option
Opportunity to work at a patient-centered, clinical-stage biopharmaceutical company at the forefront of cell therapy innovation
Collaboration with a dedicated Global Patient Safety and PV team and cross-functional experts
Role reports directly to the Senior Vice President, Head of Safety