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    Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

    Medpace
    2-4 years
    Not Disclosed
    Remote, USA
    10 Nov. 22, 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 Title: Clinical Safety Coordinator
    Company: Medpace
    Location: Taiwan

    Job Summary
    Medpace is looking for a full-time Clinical Safety Coordinator to join our Taiwan office. This critical role ensures the timely and accurate completion of key pharmacovigilance tasks and projects, directly contributing to the company’s success. If you are passionate about clinical safety and are looking for an opportunity to grow your career, this is the ideal position for you.

    Key Responsibilities

    • Collaborate closely with the Clinical Safety Manager to ensure all project deliverables are met on time.
    • Collect, process, and track serious adverse event (SAE) reports and related clinical event documents.
    • Generate and track study report safety narratives.
    • Coordinate safety surveillance activities, including lab reviews and trend analysis.
    • Prepare and distribute Investigator Safety Letters to health authorities.
    • Assist in the preparation of clinical safety documents for submission.
    • Perform safety submissions for expedited and periodic reports in Singapore, Taiwan, and China.

    Qualifications

    • Bachelor’s degree in Health/Life Sciences with 2-4 years of clinical trial safety or pharmacovigilance experience.
    • Proficient in a range of clinical safety tasks, as outlined in the responsibilities section above.
    • Strong time management skills, with the ability to work on tight timelines.
    • Ability to work independently and interact well within a team environment.
    • Proficiency in Microsoft Office and experience using safety databases efficiently.
    • High attention to detail.
    • Comprehensive knowledge of Good Clinical Practice (GCP) guidelines.

    Why Join Medpace?

    Purposeful Work

    • Be part of an organization dedicated to accelerating the global development of safe and effective medical therapeutics.

    Supportive Environment

    • Enjoy a flexible work environment and a competitive compensation package.
    • Take advantage of structured career paths and opportunities for professional growth.
    • Participate in company-sponsored appreciation events and wellness initiatives.

    About Medpace
    Medpace is a full-service clinical contract research organization (CRO) providing comprehensive clinical development services to the biotechnology, pharmaceutical, and medical device industries. We focus on ensuring the safe and effective development of medical therapeutics, leveraging local regulatory and therapeutic expertise. We have over 5,000 employees across 40+ countries, and we are headquartered in Cincinnati, Ohio.

    Awards & Recognition

    • Forbes recognized Medpace as one of America's Most Successful Midsize Companies (2021–2024).
    • Continually awarded CRO Leadership Awards from Life Science Leader Magazine based on expertise, quality, and capabilities.

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