Department: Clinical Safety
Location: Stirling
At Medpace, our European Pharmacovigilance (PV) activities are growing rapidly. As such, we are searching for motivated individuals to join our Clinical Safety team in Stirling. Working as part of a high performing group alongside Medical Monitors, Quality Assurance, Clinical Trial Management and others, this position plays a key role at Medpace to accomplish tasks and work on 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 and develop new skills, then this is the opportunity for you!
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)
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)
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
Benefits
* 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
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