Pharmacy Analyst

• 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.

• 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.

• 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.

• Bachelors degree in Pharmacy Pharmaceutical Sciences or a related field is required.

• 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.

• $110000-$130000
• Salary commensurate with experience.

DRT Strategies Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race color religion sex (including pregnancy childbirth or related conditions transgender status and sexual orientation) national origin age genetic information disability protected veteran status or any other protected characteristic under federal state or local law.

Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact Human Resources by emailing or by dialing .

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