KYVERNA is pioneering a new class of treatments and potential cures for serious autoimmune diseases. Backed by Insight Partners.
About the role
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.
What they're looking for
- 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
More about this role
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.
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
Hourly Rate : $170/hr -...
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