Safety Writer – Contract
Kyverna Therapeutics
contract
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $170 - $180 per hour
About the role
- 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
Requirements
- 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.)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingsafety assessment reportspharmacovigilanceregulatory submissionsadverse event reportingsignal detectionrisk managementFDA Information RequestsBLA submissionsSOP drafting
Soft Skills
collaborationattention to detailscientific accuracyclarityregulatory alignmenteditingformattingcommunicationorganizational skillsinspection readiness
Certifications
advanced degree in life sciencesadvanced degree in pharmacyadvanced degree in nursingadvanced degree in public health