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Kyverna Therapeutics
Kyverna Therapeutics
51 – 200 Employees
BiotechnologyPharmaceuticalsScience
Kyverna Therapeutics is a clinical-stage biotechnology and pharmaceutical company developing cell therapies for autoimmune diseases. Its research centers on CAR T-cell approaches designed to address B cell-driven conditions and potentially achieve sustained, treatment-free remission. The company’s lead candidate, KYV-101, is being evaluated in clinical trials for conditions including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Kyverna’s pipeline includes both autologous and allogeneic CAR T-cell therapies, supporting its work across autoimmune disease research and development.
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Senior Contract Safety Writer – Pharmacovigilance

Contract role focused on pharmacovigilance documentation for Kyverna Therapeutics’ autoimmune cell therapies. The work includes FDA responses, safety assessments, advisory committee materials, and related regulatory documents.

USUnited States
$170 – $190 / hour
RemoteContractSeniorLeadEnglish RequiredContent Writer

Description

  • Develop thorough safety assessment reports, including evaluations of potential safety signals
  • Draft responses to FDA Information Requests
  • Create core safety reference information and supporting rationale for label safety sections
  • Develop presentation slides for internal and external safety meetings, including FDA advisory committee sessions
  • Partner with cross-functional stakeholders to maintain complete, consistent safety narratives and analyses
  • Support risk-benefit assessments, risk management plan writing, and safety content for clinical and safety documents such as IBs and CSRs
  • Draft, revise, format, and maintain safety-related SOPs and work instructions
  • Keep SOPs aligned with applicable regulatory requirements and internal quality standards
  • Contribute to inspection-readiness activities

Requirements

  • Advanced degree in life sciences, pharmacy, nursing, public health, or a related scientific discipline; doctoral training is preferred
  • At least eight years of experience in medical writing or safety science, with substantial work on safety, clinical, or regulatory documents
  • Hands-on experience preparing documents for safety signal assessments
  • Experience developing materials for FDA advisory committees is strongly valued
  • Demonstrated ability to prepare safety-related responses to FDA Information Requests
  • Strong command of pharmacovigilance practices, including adverse event reporting, signal detection, and risk management
  • Proven ability to evaluate and interpret adverse event data
  • Familiarity with international regulatory frameworks, including EMA and PMDA requirements

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