Pharmacy Incident Data Analyst for FDA Compliance

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

Job summary

DRT Strategies, Inc. is seeking a Pharmacy Analyst to support FDA OCQC incidents program. You will apply pharmacy expertise to screen, review, and document high-volume incident reports related to compounded human drug products, under FDA guidance.

This role emphasizes data accuracy, timely follow-up, and collaboration with FDA personnel. The ideal candidate holds a BS in Pharmacy or Pharmaceutical Sciences, has experience in adverse event reporting or medication safety, and can communicate

Qualifications

• Experience with compounded drug products, medication safety, or adverse event reporting.
• Strong written and verbal communication with outreach to healthcare providers or stakeholders.
• Experience with workflow management databases or data tracking systems in 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 related to compounded drug products.
• Conduct follow-up outreach to reporters, compounders, and other stakeholders to gather factual information and document within 24 hours.
• Perform systematic quality control reviews of data entries for completeness and accuracy, and communicate observations for process improvements.

Skills

Communication skills

Regulatory/healthcare experience

Data quality control

Education

Bachelor's degree in Pharmacy or Pharmaceutical Sciences

Tools

MedWatch

Job description

DRT Strategies, Inc. is seeking a Pharmacy Analyst to support FDA OCQC incidents program. You will apply pharmacy expertise to screen, review, and document high-volume incident reports related to compounded human drug products, under FDA guidance.

This role emphasizes data accuracy, timely follow-up, and collaboration with FDA personnel. The ideal candidate holds a BS in Pharmacy or Pharmaceutical Sciences, has experience in adverse event reporting or medication safety, and can communicate