Contract safety writer to prepare BLA safety assessment reports, draft responses to FDA information requests, develop safety-related SOPs, support integrated safety summaries and risk-benefit analyses, review adverse event data, and assist with inspection readiness in collaboration with PV, clinical, regulatory, biostatistics, and medical teams.
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)
Responsibilities
- Author comprehensive safety assessment reports for inclusion in BLA submissions, ensuring scientific accuracy, clarity, and regulatory alignment
- Prepare and draft high-quality responses to FDA Information Requests related to BLA safety content
- Collaborate with Pharmacovigilance, Clinical, Regulatory Affairs, Biostatistics, and Medical teams to ensure consistency and completeness of safety narratives and analyses
- Contribute to integrated summaries of safety, risk-benefit analyses, and other safety sections required for regulatory filings
- Ensure documents comply with FDA, ICH, and global regulatory standards
- 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
- 8+ years of medical writing experience, with significant focus in pharmacovigilance and regulatory submissions
- Demonstrated experience writing safety assessment reports for BLAs
- 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
- Experience supporting FDA inspections or regulatory audits
- Familiarity with global regulatory requirements (EMA, PMDA, etc.)
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