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Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

2+ years
Not Disclosed
10 Jan. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Clinical Safety Coordinator

Location: Stirling, UK
Company: Medpace


Job Summary

Medpace is expanding its European Pharmacovigilance (PV) operations and is seeking passionate individuals to join its Clinical Safety Team in Stirling. Collaborating with professionals across diverse domains—Medical Monitors, Quality Assurance, and Clinical Trial Management—you’ll play a vital role in projects contributing to the development of life-changing medicines. This opportunity is ideal for those eager to grow their skills and take on dynamic challenges in the clinical research field.


Responsibilities

In this role, you will:

  • Case Processing and Safety Documentation:

    • Collect, process, and track serious adverse event (SAE) reports.
    • Generate safety narratives, queries, and Investigator Safety Letters.
    • Perform quality control of safety cases and enter data into safety databases.
    • Conduct SAE reconciliation between safety and clinical databases.
  • Document Management:

    • Prepare and review clinical safety documents such as safety management plans, periodic safety reports, and presentations.
    • Upload and review documents for the Trial Master File (TMF).
  • Project Oversight and Client Interaction:

    • Lead clinical trial projects, ensuring client deliverables are met with quality.
    • Provide periodic safety summaries and compliance reports to key stakeholders.
    • Attend internal and external meetings, including sponsor teleconferences, audits, and inspections.
  • Additional Responsibilities:

    • Develop and present materials for Sponsor meetings, such as Kick-off and Investigator Meetings.
    • Coordinate medical reviews and create adjudication materials.
    • Train new Clinical Safety Coordinators on safety reporting responsibilities.
    • Manage safety tasks for aggregate reporting in collaboration with Medical Monitors and Regulatory Affairs.

Qualifications

To be successful in this role, you should have:

  • Education:

    • A minimum Bachelor’s degree in life sciences or a related field.
  • Experience:

    • At least 2 years of Clinical Trial Pharmacovigilance experience.
    • Familiarity with global trials and cross-functional teams.
  • Skills:

    • Proficiency with safety databases (e.g., Argus preferred).
    • Advanced knowledge of medical terminology, global safety reporting requirements, and Good Clinical Practice (GCP) guidelines.

About Medpace

Medpace is a leading clinical contract research organization (CRO), specializing in Phase I-IV clinical development services. Over the past 30+ years, Medpace has contributed significantly to the advancement of safe and effective medical therapeutics, serving industries such as biotechnology, pharmaceuticals, and medical devices.


Why Join Medpace?

People. Purpose. Passion.

Medpace offers a collaborative and supportive work environment with numerous growth opportunities.

Benefits and Perks:

  • Flexible work environment
  • Competitive compensation and PTO packages
  • Structured career development paths
  • Employee health and wellness initiatives
  • Company-sponsored appreciation events

Awards and Recognition

  • Recognized by Forbes as one of America's Most Successful Midsize Companies (2021–2024).
  • Awarded CRO Leadership Awards for expertise, quality, and reliability.

What to Expect Next

If your qualifications match the role, you will be contacted by a Medpace team member to discuss the next steps in the application process.

Apply Today and help shape the future of healthcare with Medpace.

Medpace is an Equal Opportunity Employer. Applications are welcome from individuals of all backgrounds, including veterans and persons with disabilities.