Notice of Intent to Sole Source: Vaccine Adverse Event Reporting System (VAERS) & Safety Monitoring Support

The FDA Center for Biologics Evaluation and Research is conducting a Notice of Intent to Sole Source and seeking an 8(a) competitive contractor to provide pharmacovigilance and safety monitoring support for the Vaccine Adverse Event Reporting System (VAERS), with proposals due September 18, 2026.

The Division of Pharmacovigilance requires a senior physician to support post-market safety monitoring of vaccines and biologics approved under a Biologic Licensing Application or authorized under an Emergency Use Authorization. The contractor shall conduct pharmacovigilance activities including review and analysis of national safety surveillance databases, in-depth case report reviews with emphasis on neurological adverse events, development of informatics tools for adverse event review, and provision of technical assistance for safety assessment strategy development across vaccines, cellular and gene therapies, blood products, and tissue allografts.

The position requires a Doctor of Medicine or Doctor of Osteopathic Medicine from an accredited U.S. or Canadian school with completed residency training, current board certification (American Board of Psychiatry and Neurology preferred for neurology specialty), and minimum five years of pharmacovigilance experience including active and passive surveillance methodology and epidemiological studies. Work is performed remotely Monday through Friday, September 30, 2026 through September 29, 2027, with payment for hours delivered. Key deliverables include post-award conference summary (within two weeks), weekly core team meetings, monthly adverse event summaries, literature reviews on neurological safety issues (within 30 days of assignment), a draft program summary report (90 days prior to period end), and a final program report. The contractor must complete FDA security training and sign a Commitment to Protect Non-Public Information; overall security categorization is Moderate with two-factor authentication required.