Responsibilities
Collect, process, and track serious adverse event (SAE) reports Generate safety narratives and queries Safety Database data entry Perform quality control of safety cases Generate Investigator Safety Letters SAE reconciliation between safety database and clinical database TMF uploads and quality control review Preparation of clinical safety documents as required (i.e., safety management plan, periodic safety reports and presentations) Attending internal and external meetings, as required (including sponsor TCs and audits/inspections) Leading clinical trial projects (ensure client deliverables are met, provide oversight and compliance reports) Qualifications
Minimum Bachelor’s life science degree 2+ years of Clinical Trial Pharmacovigilance experience Working knowledge of Safety Databases (Argus is desirable) Demonstrate advanced knowledge of medical terminology, global safety reporting requirements and Good Clinical Practice (GCP) Guidelines Exposure to working on global trials as part of a multidisciplinary team
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