Project Description:The Pharmacy Analyst supports the FDA's Office of Compounding Quality and Compliance (OCQC) Incidents Program by providing technical and analytical support for incident report review related to compounded human drug products. Applies pharmacy knowledge to assist in identifying relevant product information and ensuring accurate documentation of incident details.
Job Summary:The Pharmacy Analyst provides technical and analytical assistance in the processing of high-volume incident reports related to compounded human drug products. Working under the direction of FDA government personnel, the Pharmacy Analyst applies pharmacy expertise to screen and review incoming reports, conduct follow-up outreach to gather factual information, and perform quality control checks to ensure data accuracy and completeness. This role is critical to maintaining workflow efficiency, reducing processing backlogs, and supporting FDA's ability to identify emerging safety concerns related to compounded drug products.
Responsibilities:- Conduct daily screening and review of incoming incident reports received through FDA reporting systems to identify those related to compounded drug products. Identify missing or unclear information in reports and flag reports requiring additional follow-up or government review based on FDA-established criteria.
- Conduct follow-up outreach to reporters, compounders, and other stakeholders via telephone, email, or other approved methods to gather factual information such as compounder identification and location, product details and lot numbers, and event timelines. Document all follow-up communications within 24 hours of completion and coordinate with FDA government personnel regarding follow-up priorities.
- Perform systematic quality control reviews of data entries for completeness, accuracy, consistency with source documents, and adherence to data quality standards. Identify and correct data quality errors, and communicate observations regarding recurring issues or process improvement opportunities to FDA staff.
Required Experience:- Experience with compounded drug products, medication safety, or adverse event reporting.
- Strong written and verbal communication skills, with experience conducting professional outreach to healthcare providers, compounders, or other regulated industry stakeholders.
- Experience working with workflow management databases or similar data tracking systems in a regulatory or healthcare setting.
- Experience conducting adverse event or medication safety reporting, such as through MedWatch or similar pharmacovigilance systems.
- Demonstrated experience performing data quality control reviews, including identifying and correcting errors in regulatory or clinical databases.
Preferred Experience:- Experience with compounded GLP-1 products or familiarity with telehealth-related pharmacy practices.
- Prior work in a federal regulatory or compliance environment, particularly within FDA, HHS, or a similar agency.
Education & Training:- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related field is required.
Work Authorization, Clearance Requirement, & Additional Information:- This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.
- No agencies, third parties, or Corp-to-Corp submissions.
Salary Range:- $110,000-$130,000
- Salary commensurate with experience.
