Clinical Safety Specialist

5 hours ago


Stirling, Stirling, United Kingdom Medpace Full time
Job Overview

This role involves collecting, processing, and tracking serious adverse event reports to support the development of life-changing medicines.

Responsibilities
  • Collect, process, and track SAE reports for the development of life-changing medicines.
  • Generate safety narratives and queries to ensure compliance with GCP Guidelines.
  • Perform quality control of safety cases and data entry into safety databases.
  • Prepare clinical safety documents, such as safety management plans and periodic safety reports.
  • Attend internal and external meetings to ensure client deliverables are met.
Additional Responsibilities
  • Develop presentation material and present during face-to-face Sponsor meetings.
  • Coordinate final medical review of study report narratives and submission to Medical Writers.
  • Develop drafts of adjudication material, such as reporting materials.
  • Provide periodic safety summaries to project stakeholders.
  • Train new Clinical Safety Coordinators on safety reporting responsibilities.
  • Coordinate safety responsibilities for aggregate reporting purposes.
Qualifications
  • Bachelor's degree in a life science.
  • 2+ years of Clinical Trial Pharmacovigilance experience.
  • Working knowledge of Safety Databases, preferably Argus.
  • Demonstrate advanced knowledge of medical terminology and global safety reporting requirements.
  • Experience working on global trials as part of a multidisciplinary team.

Estimated Salary: £45,000 - £65,000 per annum.



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