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.
Position Overview
Kyverna is seeking a Contract Safety Writer – Pharmacovigilance (Consultant) with deep expertise in Pharmacovigilance to support critical regulatory and safety documentation activities. This individual will play a key role in preparing high-quality safety assessment documents for Biologics License Applications (BLA), drafting responses to FDA Information Requests (IRs), and supporting the development and refinement of safety-related Standard Operating Procedures (SOPs). The ideal candidate combines strong scientific writing skills with hands-on experience reviewing adverse event data and translating complex safety analyses into clear, regulatory-compliant documentation.
Title: Safety Writer – Contract
Location: Remote eligible
Hourly Rate: $170/hr - $180/hr
Duration: 6+ months (30+ hours per week)
ResponsibilitiesAuthor comprehensive safety assessment reports for inclusion in BLA submissions, ensuring scientific accuracy, clarity, and regulatory alignmentPrepare and draft high-quality responses to FDA Information Requests related to BLA safety contentCollaborate with Pharmacovigilance, Clinical, Regulatory Affairs, Biostatistics, and Medical teams to ensure consistency and completeness of safety narratives and analysesContribute to integrated summaries of safety, risk-benefit analyses, and other safety sections required for regulatory filingsEnsure documents comply with FDA, ICH, and global regulatory standardsAssist in drafting, editing, formatting, and maintaining safety-related SOPs and associated work instructionsEnsure SOPs align with current regulatory requirements and internal quality standardsSupport inspection readiness activities as neededQualificationsAdvanced degree in life sciences, pharmacy, nursing, public health, or related scientific field8+ years of medical writing experience, with significant focus in pharmacovigilance and regulatory submissionsDemonstrated experience writing safety assessment reports for BLAsExperience drafting responses to FDA Information Requests related to safetyStrong understanding of pharmacovigilance principles, including adverse event reporting, signal detection, and risk managementProven ability to review and interpret adverse event dataExperience supporting FDA inspections or regulatory auditsFamiliarity with global regulatory requirements (EMA, PMDA, etc.)
