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Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

3-5 years
Preferred by Comapny
11 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: Stirling, United Kingdom
Department: Clinical Safety
Job ID: 9362


Overview

Medpace is expanding its European Pharmacovigilance (PV) operations and is seeking motivated individuals to join the Clinical Safety team in Stirling. This role is essential for supporting the pharmacovigilance process, working with a multidisciplinary team to achieve Medpace's mission of advancing life-changing medicines.

If you are eager to develop new skills in a dynamic environment while contributing to the development of therapeutics, this is the opportunity for you!


Key Responsibilities

  • Adverse Event Management:

    • Collect, process, and track serious adverse event (SAE) reports.
    • Generate safety narratives and queries.
  • Database and Reporting:

    • Perform safety database data entry and quality control of safety cases.
    • Generate Investigator Safety Letters.
    • Reconcile SAEs between the safety and clinical databases.
  • Document Preparation:

    • Prepare clinical safety documents such as safety management plans, periodic safety reports, and presentations.
    • Conduct TMF uploads and quality control reviews.
  • Project Leadership:

    • Lead clinical trial projects to meet client deliverables and provide oversight reports.
  • Client Interaction:

    • Develop presentation materials for Sponsor meetings, including Kick-off Meetings and Investigator Meetings.
    • Attend internal and external meetings (e.g., audits, sponsor calls).
  • Training and Coordination:

    • Train new Clinical Safety Coordinators on safety reporting.
    • Collaborate with Medical Monitors and Regulatory Affairs for aggregate reporting purposes.

Qualifications

  • Education:

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

    • At least 2 years of experience in Clinical Trial Pharmacovigilance.
    • Knowledge of safety databases (e.g., Argus) is preferred.
  • Skills and Knowledge:

    • Advanced understanding of medical terminology and global safety reporting requirements.
    • Familiarity with Good Clinical Practice (GCP) Guidelines.
    • Experience working on global trials within multidisciplinary teams.

Why Join Medpace?

Benefits and Perks

  • Flexible work environment.
  • Competitive compensation and benefits package.
  • Comprehensive PTO packages.
  • Structured career paths with opportunities for professional development.
  • Participation in employee appreciation events.

Global Impact

  • Medpace has been a leader in clinical development services for over 30 years.
  • Recognized among America’s Most Successful Midsize Companies by Forbes (2021–2024).
  • Award-winning quality and reliability in clinical research.

About Medpace

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV development services to the biotechnology, pharmaceutical, and medical device industries. With over 5,000 employees in 40+ countries, Medpace is dedicated to accelerating the development of safe and effective medical therapeutics through its scientific and disciplined approach.

Join us today to make a difference tomorrow.

Apply now for Job ID 9362 and be part of a team transforming lives!