Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

In this role you support the Clinical Safety team to advance safety activities for global trials. You will work with Medical Monitors, QA, and trial managers to process SAE reports, generate safety narratives, and ensure data integrity across safety and clinical databases. You’ll contribute to safety documentation, participate in sponsor meetings, and help drive project outcomes with a focus on compliance and timely deliverables. This is a hands-on role in a fast-growing PV group offering opportunities to develop skills in a collaborative, cross-functional environment.

• flexible work environment
• competitive compensation and benefits package
• competitive PTO packages
• structured career paths with opportunities for professional growth
• company-sponsored employee appreciation events
• employee health and wellness initiatives

• Collect, process, and track SAE reports
• Generate safety narratives and queries
• Safety database data entry
• Quality control of safety cases
• Generate Investigator Safety Letters
• SAE reconciliation between safety and clinical databases
• TMF uploads and QC review
• Prepare clinical safety documents (e.g., safety management plan, periodic safety reports)
• Attend internal/external meetings (sponsor TCs, audits/inspections)
• Lead clinical trial projects to meet client deliverables and provide oversight/compliance reports
• Develop presentation material for Sponsor meetings and timelines
• Coordinate final medical review of study report narratives and submission to Medical Writers
• Develop drafts of adjudication material (charter, reporting materials)
• Provide periodic safety summaries to project Data Manager, CTM, and Medical Monitor
• Train new Clinical Safety Coordinators on safety reporting responsibilities
• Coordinate safety responsibilities for aggregate reporting (data entry, pending cases) in collaboration with Medical Monitor and Regulatory Affairs

• 2+ years of Clinical Trial Pharmacovigilance experience
• Working knowledge of Safety Databases (Argus desirable)
• Advanced knowledge of medical terminology, global safety reporting requirements, and GCP
• Experience on global trials as part of a multidisciplinary team

• strong communication
• attention to detail
• team-oriented collaboration
• SAE processing and safety reconciliation
• safety database data entry
• generation of safety narratives and letters