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Clinical-Safety-Coordinator-Pharmacovigilance-Drug-Safety

0-2 years
Preferred by Comapny
10 Nov. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opening: Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

Location: London, United Kingdom
Department: Clinical Safety
Job ID: 9940


Overview

Medpace is seeking a motivated Clinical Safety Coordinator to join its growing European Pharmacovigilance (PV) team in London. This role offers a dynamic work environment, collaborating with Medical MonitorsQuality AssuranceClinical Trial Management, and other multidisciplinary teams to support the development of life-changing medicines.

If you are passionate about clinical safety and want to apply your skills in a global setting while developing further, this opportunity is for you.


Key Responsibilities

Core Responsibilities:

  • SAE Management:

    • Collect, process, and track serious adverse event (SAE) reports.
    • Conduct SAE reconciliation between the safety database and clinical database.
  • Documentation and Reporting:

    • Generate safety narratives, queries, and Investigator Safety Letters.
    • Upload and perform quality control (QC) reviews of Trial Master File (TMF) documents.
    • Draft clinical safety documents (e.g., safety management plans, periodic reports, presentations).
  • Database and Oversight:

    • Perform safety database data entry and QC of safety cases.
    • Coordinate final medical reviews and submissions for study reports.

Leadership and Coordination:

  • Lead clinical trial projects, ensuring client deliverables are met.
  • Provide oversight and compliance reporting for safety activities.
  • Train new Clinical Safety Coordinators in safety reporting responsibilities.

Additional Responsibilities:

  • Prepare and deliver presentations during sponsor meetings (e.g., Kick-Off MeetingsInvestigator Meetings).
  • Collaborate on adjudication material development (e.g., charters, reporting materials).
  • Provide periodic safety summaries to internal teams, including Data Managers and Medical Monitors.

Qualifications

  • Education:

    • Bachelor’s degree in a life science discipline.
  • Experience:

    • Minimum 2+ years of pharmacovigilance experience in clinical trials.
    • Familiarity with safety databases (e.g., Argus is preferred).
    • Knowledge of global safety reporting requirements and Good Clinical Practice (GCP) guidelines.
  • Skills:

    • Proficiency in medical terminology and global trial processes.
    • Ability to work collaboratively in multidisciplinary teams.

Why Join Medpace?

Perks and Benefits

  • Flexible work environment.
  • Competitive compensation and benefits package.
  • Generous Paid Time Off (PTO).
  • Structured career paths with professional growth opportunities.
  • Participation in employee wellness programs and appreciation events.

Global Impact

  • Over 30 years of advancing therapeutic solutions.
  • Recognized as one of America’s Most Successful Midsize Companies (Forbes, 2021–2024).
  • Recipient of multiple CRO Leadership Awards for quality and reliability.

How to Apply

Interested candidates can apply for Job ID 9940 through the Medpace Career Portal.

Be part of a team that is transforming global healthcare and making a real difference in patients’ lives while advancing your career in pharmacovigilance.