Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

At Medpace our European Pharmacovigilance (PV) activities are growing rapidly, as such we are searching for motivated individuals to join our Clinical Safety team. This position plays a key role in Clinical Safety at Medpace. Working as an integral part of a high performing Clinical Safety group, alongside our colleagues (Medical Monitors, Clinical Trial Managers…) to accomplish tasks and projects that are instrumental to the development of life changing medicines. If you want an exciting career where you can apply yourself to a variety of opportunities, develop new skills and develop even further, then this is the opportunity for you!Where you’ll work

Based at either our Stirling or London office, Medpace offers hybrid working solutions upon completion of probation.

Company sponsorship in not available for this role.

• 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)

Additional Responsibilities

• Develop presentation material and present during face-to-face Sponsor meetings (i.e., Kick-off Meetings, Investigator Meetings)
• Coordinate final medical review of study report narratives and submission to Medical Writers
• Develop drafts of adjudication material (i.e., charter, reporting materials)
• Provide periodic safety summaries to project Data Manager, Clinical Trial Manager, and Medical Monitor
• Train new Clinical Safety Coordinators on safety reporting responsibilities
• Coordinate safety responsibilities for aggregate reporting purposes (e.g., ensure timely data entry, tracking of pending cases, collaborate with Medical Monitor and Regulatory Affairs)

• Bachelor’s life science degree
• Experience in Pre-Market Clinical Trial Pharmacovigilance (4+ years)
• 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 trails as part of a multidisciplinary team