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    Clinical-Safety-Coordinator-Pharmacovigilance-Drug-Safety

    Medpace
    0-2 years
    Preferred by Comapny
    Lombard
    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 Monitors, Quality Assurance, Clinical 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 Meetings, Investigator 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.

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    Bucharest |

    Makkah :

    Khulais | Jeddah | Riyadh | Rabigh | Najran | King Abdullah Economic City |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |