Pharmacy Incident Analyst: Regulatory Data QC

DRT Strategies; Silver Spring (MD); On-site; USD 110,000 - 130,000; Full time

Job summary

DRT Strategies, Inc. (DRT) is seeking a Pharmacy Analyst to support the FDA OCQC incidents program by processing high-volume reports and applying pharmacy expertise to ensure accurate documentation.

Working under FDA personnel, you will screen reports, perform follow-up outreach to gather facts, and run quality checks to maintain data integrity and support safety surveillance for compounded drug products.

Qualifications

• 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 or regulators.
• Experience with workflow management databases or data tracking systems in regulatory/healthcare settings.
• Experience conducting adverse event or medication safety reporting (MedWatch or similar).
• Data quality control reviews in regulatory or clinical databases.

Responsibilities

• Screen incoming incident reports to identify those related to compounded drug products.
• Follow up with reporters and stakeholders to gather factual information.
• Perform quality control reviews to ensure data accuracy and completeness.

Skills

Pharmacy knowledge

Regulatory communication

Data quality control

MedWatch pharmacovigilance

Education

Bachelor's degree in Pharmacy

Job description

DRT Strategies, Inc. (DRT) is seeking a Pharmacy Analyst to support the FDA OCQC incidents program by processing high-volume reports and applying pharmacy expertise to ensure accurate documentation.

Working under FDA personnel, you will screen reports, perform follow-up outreach to gather facts, and run quality checks to maintain data integrity and support safety surveillance for compounded drug products.