FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Safety Writer – Contract
Kyverna Therapeutics. Author comprehensive safety assessment reports, including signal evaluations .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing and safety assessment, with a strong focus on regulatory compliance and pharmacovigilance principles. Proficient in drafting safety-related documents and collaborating with cross-functional teams to ensure quality and consistency.
Highest-signal resume keywords
Medical WritingSafety Signal AssessmentFDA Information RequestsPharmacovigilance PrinciplesRegulatory Requirements
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety Assessment ReportsRisk-Benefit AnalysesRMP WritingClinical DocumentsSOP DraftingAdverse Event ReportingSignal DetectionData Interpretation
Soft Skills
CollaborationCommunication
Industry Keywords
Life SciencesPharmacyNursingPublic HealthFDA Advisory CommitteesGlobal Regulatory RequirementsEMAPMDA
About the role
Key responsibilities & impact- Author comprehensive safety assessment reports, including signal evaluations
- Prepare and draft responses to FDA Information Requests
- Prepare and draft core safety reference information or justification for safety sections of labels
- Prepare and draft slides for safety-related presentations for internal and external meetings, including FDA advisory committee meetings
- Collaborate with cross-functional teams to ensure consistency and completeness of safety narratives and analyses
- Contribute to risk-benefit analyses, RMP writing, and safety sections for clinical and safety documents, including IBs and CSRs
- Assist in drafting, editing, formatting, and maintaining safety-related SOPs and work instructions
- Ensure SOPs align with current regulatory requirements and internal quality standards
- Support inspection readiness activities
Requirements
What you’ll need- 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.)