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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: London, UK
Company: Medpace


Job Summary

Medpace is expanding its European Pharmacovigilance (PV) activities and is seeking motivated individuals to join the Clinical Safety Team in London. This role offers the opportunity to work in a collaborative, multidisciplinary environment, contributing to the development of life-changing medicines. If you’re looking to enhance your career with new challenges and skill-building opportunities, this position is ideal for you.


Responsibilities

As a Clinical Safety Coordinator, your responsibilities will include:

  • Safety Case Management:

    • Collect, process, and track serious adverse event (SAE) reports.
    • Generate safety narratives and queries.
    • Perform quality control of safety cases.
    • Data entry in the safety database and SAE reconciliation with the clinical database.
  • Clinical Safety Documentation:

    • Prepare safety management plans, periodic safety reports, and presentations.
    • Generate Investigator Safety Letters.
    • Upload and review documents in the Trial Master File (TMF).
  • Project Leadership and Oversight:

    • Lead clinical trial projects to ensure client deliverables are met.
    • Provide compliance reports and oversight.
    • Coordinate periodic safety summaries with project teams.
  • Additional Responsibilities:

    • Develop presentation materials for Sponsor meetings (e.g., Kick-off Meetings, Investigator Meetings).
    • Coordinate final medical reviews and adjudication materials.
    • Train new Clinical Safety Coordinators in safety reporting.
    • Collaborate with Medical Monitors and Regulatory Affairs for aggregate reporting purposes.

Qualifications

To qualify for this role, you need:

  • Education:

    • Minimum of a Bachelor’s degree in life sciences.
  • Experience:

    • At least 2 years of Clinical Trial Pharmacovigilance experience.
    • Exposure to global trials and multidisciplinary teams.
  • Skills:

    • Working knowledge of safety databases (e.g., Argus is desirable).
    • Advanced knowledge of medical terminology, global safety reporting requirements, and Good Clinical Practice (GCP) Guidelines.

About Medpace

Medpace is a global clinical contract research organization (CRO) specializing in Phase I-IV clinical development services. For over 30 years, Medpace has been dedicated to accelerating the development of safe and effective medical therapeutics across therapeutic areas like oncology, endocrinology, cardiology, and infectious diseases.


Why Medpace?

People. Purpose. Passion.

Medpace fosters a supportive environment where employees can make a tangible difference in healthcare.

Perks and Benefits:

  • Flexible work environment
  • Competitive compensation and benefits
  • Generous PTO packages
  • Opportunities for professional growth
  • Employee wellness initiatives

Awards and Recognition

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

What to Expect Next

If your qualifications match the role, a Medpace team member will contact you with details on the next steps in the application process.

Apply Today to take the next step in your career and contribute to life-changing medical advancements.


Medpace is an Equal Opportunity/Affirmative Action Employer. We welcome applications from individuals of diverse backgrounds, including those with disabilities, veterans, and underrepresented groups.