Job Title
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.
