Safety Writer/Scientist - Contract

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.)