Clinical Safety Specialist

1 month ago


London, Greater London, United Kingdom Bancroft School Full time
Job Description

We are seeking a highly motivated Clinical Safety Specialist to join our European Pharmacovigilance team in London. As part of a high-performing group, you will play a key role in accomplishing tasks and working on projects that contribute to the development of life-changing medicines.

Responsibilities:
  • Collect, process, and track serious adverse event 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).
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.

This position offers an estimated salary of £45,000 - £55,000 per annum, depending on experience. We also offer competitive benefits and opportunities for career growth.



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