SAM #CBER-2026-133723

FDA Sole Source Contract for Senior Physician Pharmacovigilance Support (Neurology) for VAERS & Biologics Safety Monitoring

This opportunity is a sole source contract from the FDA's Center for Biologics Evaluation and Research (CBER) for expert support services related to vaccine and biologics safety monitoring. - Agency: Food and Drug Administration (FDA), CBER, Office of Biostatistics and Pharmacovigilance, Division of Pharmacovigilance - Contract Type: Sole source, set aside for 8A businesses - Scope: - Support for the Vaccine Adverse Event Reporting System (VAERS) - Safety monitoring for vaccines, cellular and gene therapies, and blood products - Senior physician expertise required, specifically in neurology - Tasks include safety surveillance, data analysis, literature reviews, and report preparation - Requirements: - Doctor of Medicine with board certification in neurology - Minimum 5 years of pharmacovigilance experience - Deliverables: - Monthly reports, literature reviews, program summaries - No specific products, part numbers, or OEMs are named - Period of performance: September 30, 2026 – September 29, 2027 (one year) - Commercial opportunity for qualified 8A businesses with relevant medical and pharmacovigilance expertise

Description

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)’s Office of Biostatistics and Pharmacovigilance (OPBV)’s Division of Pharmacovigilance (DPV) is responsible for monitoring the safety of vaccines and biologics once they are approved for use under a Biologic Licensing Application (BLA) or authorized for use under an Emergency Use Authorization (EUA).

The Contractor shall furnish the necessary services and qualified personnel needed to perform the Statement of Work.

View original listing