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Senior Physician Subject Matter Expert (SME) - Pharmacovigilance

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Carmel, CA, 93923, USA

Set-Aside

8A

Documents

This scope was carved out of CBER-2026-133723.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

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

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acq Grant Svcs
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Office AddressN/A
ContactsNo contact information available

Full Description

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Performs medical review and analysis of adverse event reporting systems for prime contractors on FDA CBER projects. Monitors and analyzes national safety surveillance databases and industry-submitted safety data, focusing on neurological adverse events of special interest. Requires an MD/DO with senior-level pharmacovigilance experience and regulatory agency background. Delivers medical safety reviews, signal analysis reports, and expert consultations.

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