About the role
Job | Kyverna Therapeutics Platform & Pipeline Opportunity CAR T-Cell Therapy Pipeline Clinical Trials and Expanded Access Patients Experience Stiff Person Syndrome Myasthenia Gravis Multiple Sclerosis Lupus Nephritis Systemic Sclerosis Inside Kyverna Leadership Mission & Values Education & Events Publications Videos Investors News Careers Contact --> ← Back Associate Director, Safety and Pharmacovigilance Emeryville, CA Drug Safety/Pharmacovigilance Full Time Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible. Title: Associate Director, Safety and Pharmacovigilance Reports to: Senior Vice President, Head of Safety Location: Emeryville, CA (Hybrid) or remote Summary 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. The individual will contribute across case/vendor oversight, compliance, signal management, aggregate reporting, and benefit-risk evaluation.
Responsibilities General Ensure adherence to report timelines and communicate issues to management as appropriate Develop and maintain an expert understanding of the latest safety regulations, technology, and safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease indication, safety profile of competitors, mechanism of action) PV Operations/Quality Assurance Manage and support the relationship with safety vendors to ensure effectiveness, quality and compliance of all outsourced activities in collaboration with Director of PV operations. Lead oversight of quality and key performance indicators (case processing and aggregate reports) and present findings to Head of PV and relevant cross-functional stakeholders. Serve as resource for inspections and audits Ensure operational outputs support high-quality scientific safety assessment Clinical Safety and Safety Science Lead signal detection and management activities, including literature search, data analyses, preparation of safety data for cross-functional safety team meetings, and drafting presentations and regulatory responses, in collaboration and consultation with the safety physician. Lead the drafting of safety sections of IB, aggregate reports (e.g. PADERs, PSURs, PBRERs, DSURs), and Risk Management Plans etc., in collaboration and consultation of the safety team and the cross-functional teams. Support and contribute to global regulatory submissions (e.g. drafting response to Health Authority requests, authoring and reviewing submission packages, etc.) with the safety team and the cross-functional experts. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and