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Safety Writer/Scientist – Contract

Kyverna Therapeutics

Role overview

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
  • Strong understanding of pharmacovigilance principles, including adverse event reporting, signal detection, and risk management

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
  • Collaborate with cross-functional teams to ensure consistency and completeness of safety narratives and analyses

Key facts

  • Remote from: United States
  • Freelance
  • Senior (5-10 years)
  • English

Hard skills

Other skills

  • Collaboration
  • Detail Oriented

About the company

Kyverna Therapeutics logo

Kyverna Therapeutics

Biotechnology

Kyverna is a clinical-stage biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience.

Company details

IndustryBiotechnology
Company size51-200

Links

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Job description

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/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.)
    •

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    MR

    Marcus Rivera

    Chief Revenue Officer

    m.rivera@company.com
    linkedin.com/in/marcusrivera
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