Senior Drug Safety Systems Analyst - Hybrid Remote

Technical Resources International, Inc.; Bethesda (MD); Hybrid; USD 100,000 - 120,000; Full time

Job summary

Technical Resources International, Inc. (TRI) is seeking a Senior Drug Safety Systems Analyst in Bethesda, MD. The role focuses on Adverse Event reporting, data integration, and safety system configurations to support regulatory submissions.

Responsibilities include developing automated QC checks, maintaining ICSR workflows, and collaborating with PVG, IT, QA, Regulatory Operations and clients to ensure timely safety reporting.

Qualifications

• Proficiency in data transformation, reconciliation and QC checklists.
• Working knowledge of relational data, SQL, and SAS.
• Experience translating clinical reqs into traceable specs and reproducible reporting workflows.

Responsibilities

• Ensure compliance with SOPs, FDA, WHO and global reporting requirements for adverse events.
• Collect, report and share adverse event information for marketed drugs and investigational agents.
• Maintain agent-specific summaries for toxicology studies of investigational agents.
• Perform literature searches and adverse event analysis for safety.
• Support DSUR development and safety dashboards and reports.
• Review protocols, informed consent documents and prepare safety presentations.

Skills

SQL

SAS

Data transformation

Documentation & reporting

Communication

Education

Master's Degree in a related field

Tools

Oracle Argus

XML

E2B(R2/R3)

Web Services

Job description

Technical Resources International, Inc. (TRI) is seeking a Senior Drug Safety Systems Analyst in Bethesda, MD. The role focuses on Adverse Event reporting, data integration, and safety system configurations to support regulatory submissions.

Responsibilities include developing automated QC checks, maintaining ICSR workflows, and collaborating with PVG, IT, QA, Regulatory Operations and clients to ensure timely safety reporting.