More jobs:
Safety Writer
Job in
Oxnard, Ventura County, California, 93033, USA
Listed on 2026-03-05
Listing for:
Virtual Vocations Inc
Contract
position Listed on 2026-03-05
Job specializations:
-
Healthcare
Medical Science Liaison, Healthcare Compliance
Job Description & How to Apply Below
A company is looking for a Safety Writer - Contract.
Key Responsibilities Author comprehensive safety assessment reports for BLA submissions, ensuring scientific accuracy and regulatory alignment Prepare and draft responses to FDA Information Requests related to BLA safety content Collaborate with various teams to ensure consistency and completeness of safety narratives and analyses Qualifications Advanced degree in life sciences, pharmacy, nursing, public health, or related scientific field 8+ years of medical writing experience, with a focus on 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 and global regulatory requirements
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