Clinical Safety Analyst
Core
Evaluates and ensures the quality of clinical trial patient safety data through timely review, analysis, and reporting to support global safety surveillance.
Role type
Clinical Safety Analyst
Builds
Safety reports, narratives of serious adverse events, and study safety reviews
Domain
Clinical trials, patient safety, regulatory compliance (ICH, FDA, EMA)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial life cycle management, safety data analysis, regulatory guidance adherence, protocol review, serious adverse event narrative creation, database proficiency (Oracle, PIMS), critical thinking
Preferred skills
RN or clinical pharmacy experience, drug safety experience, process improvement project participation
Technologies
Oracle, PIMS, Windows, Word, Excel
Responsibilities
Assess reported clinical trial data and participate in safety surveillance activities, review and analyze safety-related data for trends and quality, monitor safety queries to investigators, plan and execute study safety review plans, provide safety overviews to clinical teams and investigators, review study protocols for safety language, review safety sections of clinical study reports, create narratives of serious adverse events
Seniority
Mid-level, hands-on IC
