FDA Incident Data Analyst: Pharmacy & Compliance

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

Benefits offered by this job

Disability accommodations

Competitive benefits package

Job summary

DRT Strategies, Inc. is seeking a Pharmacy Analyst to support the FDA's OCQC Incidents Program by reviewing incident reports related to compounded human drug products.

You will apply pharmacy expertise to gather factual information, perform follow-ups, and ensure data accuracy under supervision of FDA personnel. The role emphasizes processing high-volume reports, reducing backlogs, and identifying emerging safety concerns in compounded drugs through meticulous data review and outreach to

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, 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.

Responsibilities

• Conduct daily screening and review of incoming incident reports to identify those related to compounded drug products.
• Follow-up with reporters, compounders, and other stakeholders via telephone or email to gather factual information and document communications.
• Perform quality control reviews of data entries for completeness and accuracy, and communicate observations to FDA staff.

Skills

Pharmacy knowledge

Written and verbal communication

Regulatory outreach

Data quality control

Education

Bachelor's degree in Pharmacy or Pharmaceutical Sciences

Tools

Workflow management databases

Regulatory databases

Job description

DRT Strategies, Inc. is seeking a Pharmacy Analyst to support the FDA's OCQC Incidents Program by reviewing incident reports related to compounded human drug products.

You will apply pharmacy expertise to gather factual information, perform follow-ups, and ensure data accuracy under supervision of FDA personnel. The role emphasizes processing high-volume reports, reducing backlogs, and identifying emerging safety concerns in compounded drugs through meticulous data review and outreach to