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/Scientist – Pharmacovigilance (Consultant) with deep expertise in Safety/Pharmacovigilance to support critical regulatory and medical safety documentation activities. This individual will play a key role in preparing high-quality safety regulatory documents, such as drafting responses to FDA clinical or postmarket Information Requests (IRs), supporting external advisory committee meetings, safety related clinical and medical inquiries, etc. The ideal candidate combines strong scientific writing skills with hands-on experience translating complex safety analyses into clear, regulatory-compliant documentation.
Title: Safety Writer/Scientist – Contract
Location: Remote eligible
Hourly Rate: $170/hr - $190/hr
Duration: 6+ months (20-30 hours per week)
Responsibilities
- Author comprehensive safety assessment reports (including signal evaluations), ensuring scientific accuracy, clarity, and regulatory alignment
- Prepare and draft high-quality responses to FDA Information Requests as needed
- Prepare and draft core safety reference information or justification for safety sections of the label
- Prepare and draft slides for safety related presentations for both internal and external meetings, including FDA advisory committee meeting.
- Collaborate with cross-functional teams to ensure consistency and completeness of safety narratives and analyses
- Contribute to risk-benefit analyses, RMP writing, and other safety sections required for various clinical and safety documents (IB, CSR, etc)
- Assist in drafting, editing, formatting, and maintaining safety-related SOPs and associated work instructions
- Ensure SOPs align with current regulatory requirements and internal quality standards
- Support inspection readiness activities as needed
Qualifications
- Advanced degree in life sciences, pharmacy, nursing, public health, or related scientific field (doctorate level preferred)
- 8+ years of medical writing/safety scientist experience, with significant focus in safety, clinical, or regulatory documents.
- Experience with writing safety signal assessment documents.
- Prior experience with writing and preparation for FDA advisory committees is highly valued.
- Demonstrated experience drafting responses to FDA Information Requests related to safety
- Strong understanding of pharmacovigilance principles, including adverse event reporting, signal detection, and risk management
- Proven ability to review and interpret adverse event data
- Familiarity with global regulatory requirements (EMA, PMDA, etc.)
Skills Required
- Advanced degree in life sciences, pharmacy, nursing, public health, or a related scientific field
- Doctorate-level education
- 8+ years of medical writing or safety scientist experience, with significant focus on safety, clinical, or regulatory documents
- Experience writing safety signal assessment documents
- Experience writing and preparing materials for FDA advisory committees
- Experience drafting responses to FDA Information Requests related to safety
- Strong understanding of pharmacovigilance principles, including adverse event reporting, signal detection, and risk management
- Ability to review and interpret adverse event data
- Familiarity with global regulatory requirements, including EMA and PMDA
What We Do
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Using its SmarTcell™ approach which includes synReg-T cell and synNotch CAR-T technology platforms, Kyverna reprograms T cells to target and selectively suppress or eliminate autoreactive immune cells. The company’s goal is to develop therapies that are selective, potent and durable to tame autoimmunity. We build interdisciplinary teams that bring a broad range of experiences and scientific expertise together to develop medicines that will free patients from the siege of autoimmune diseases and bring curiosity for exploring and creating the unknown. Our commitment to our employees is to foster an open, supportive, and inclusive environment where we create opportunities for individuals to learn and grow to their full potential at every level. synNotch is a trademark of Gilead/Kite.
