Senior Drug Safety Systems Analyst

Location

Bethesda, MD 20817 US (Primary)

Category

Drug Safety

Job Type

Full-Time

Salary Range

$100,000-$120,000

Education

Master's Degree

Travel

None

Job Description

• Ensure compliance with TRI Standard Operating Procedures, Food and Drug Administration regulations, World Health Organization (WHO) guidance, and applicable global requirements for reporting adverse events to regulatory agencies.
• Support clinical research by collecting, reporting, and sharing adverse event information and related findings for marketed drugs and investigational agents.
• Maintain and update agent-specific summary tables of clinical and preclinical toxicity studies for investigational agents.
• Perform literature searches.
• Support clinical research through adverse event analysis and processing, and serious adverse event reconciliation.
• Review experimental protocols and informed consent documents, as needed, and prepare, review, and edit presentations on safety issues.
• Develop and maintain specifications, mappings, validation rules, and reconciliation controls for E2B Individual Case Safety Report (ICSR) transfers and safety-system interfaces.
• Develop line listing comparisons, safety listings, summaries, reconciliations, dashboards, and periodic reports, including outputs supporting the Development Safety Update Report (DSUR).
• Develop metrics to monitor ICSR processing and regulatory submission timelines and due dates.
• Configure Oracle Argus studies, develop automated ICSR quality control (QC) tools, and review case reporting rules, code lists, and auto-narrative templates in Argus after completing required training and obtaining authorization.
• Translate Safety Management Plan and Statement of Work requirements into database mappings, workflow controls, QC checklists, escalation trackers, and traceable test evidence.
• Develop automated checks for case completeness, narrative consistency, chronology, reportability workflows, and submission readiness, including query generation for discrepancies or incorrect clinical information, while preserving required human review.
• Develop and automate reports summarizing Excel comparison results and study information.
• Collaborate with PVG, medical reviewers, IT, Quality Assurance, Regulatory Operations and clients, and escalate risks that could affect quality or reporting timelines.
• Provide technical support for systems that facilitate the exchange of safety-related data between clinical and safety databases.
• Support the data integration aspects of MedDRA and WHO Drug Dictionary coding tasks.

Job Requirements

• Demonstrated proficiency in data transformation, reconciliation, and programming QC checklists, along with a working knowledge of relational data, SQL, and SAS.
• Experience translating clinical research requirements into traceable specifications, validated checks, and reproducible reporting workflows in a regulated environment.
• Excellent written and verbal communication skills, including the ability to prepare documentation, deliver client-facing presentations, facilitate productive meetings, and explain complex information to technical and nontechnical audiences. Ability to collaborate across functions, manage multiple priorities, and escalate risks promptly.
• Ability to complete required training and demonstrate competency before independently implementing safety-system configurations, mappings, interfaces, or submission changes.
• Experience with Oracle Argus Safety Console, configuration of studies and expedited workflow, XML, E2B(R2/R3), ICSR data exchange through gateway or web service integrations, comparable data intake systems, and FAERS or other electronic submission systems preferred.
• Experience with safety and clinical datasets, regulatory submissions, DSUR outputs, and dashboards.
• Experience developing automated QC checklists, reconciliation tools, reports, auto-narratives, and reusable validated automation.
• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.