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    Pharmacovigilance Reporting Associate

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    0-2 years
    Not Disclosed
    Remote, USA
    10 Nov. 8, 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

    About ICON plc

    ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to shaping the future of clinical development. We foster a culture of innovation and excellence, creating an inclusive environment where all team members can thrive. Join us in our mission to improve healthcare outcomes worldwide.

    Role Overview

    We are seeking a Pharmacovigilance Reporting Associate to join our team at the ICON Taipei office. In this role, you will support the accurate and timely reporting of safety information related to clinical trials and pharmacovigilance activities. You will ensure compliance with regulatory requirements, client expectations, and ICON standards.

    Key Responsibilities

    • Safety Reporting:

      • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety information to clients, regulatory authorities, ethics committees, investigators, and third-party vendors.
      • Release safety reporting intelligence for expedited and periodic reports in accordance with company procedures and timelines.
      • Ensure that all safety reports are submitted within specified timelines in compliance with project requirements.

    • Project Oversight:

      • Monitor project timelines and ensure ICON, sponsor, and regulatory deadlines are met for safety reporting activities.
      • Take ownership and accountability for safety reporting activities on assigned projects, ensuring accuracy and timeliness in line with ICON standards and client expectations.
      • Operate in a lead capacity to ensure all reporting activities are completed in compliance with regulations and client contractual obligations.

    • Collaboration & Communication:

      • Work closely with project team members, client contacts, investigators, and third-party vendors to ensure the smooth execution of safety reporting activities.
      • Represent the Safety Reporting department in client meetings and internal discussions, providing updates on project status and addressing any issues as needed.

    • Quality Control & Filing:

      • Maintain and update project information within pharmacovigilance databases, ensuring timely and accurate data entry.
      • Oversee the filing and quality control of documents in eTMF or agreed filing solutions, ensuring file readiness for audits or inspections.
      • Prepare for audits and inspections, providing necessary documentation and support.

    • Mentoring & Training:

      • Mentor and coach less experienced associates on safety reporting activities.
      • Assist in the training and development of new team members on pharmacovigilance processes and regulatory requirements.

    • Regulatory Knowledge:

      • Stay updated on current regulations and safety reporting practices to ensure compliance with the latest industry standards.
      • Review regulatory and safety reporting intelligence documents to ensure ongoing alignment with regulatory requirements.

    • Additional Duties:

      • Perform additional project activities as requested, including presentations at client or investigator meetings, client correspondence, and escalating issues as needed.
      • Travel (approximately 10%) domestically or internationally to support project needs.

    What ICON Can Offer You

    At ICON, our success depends on the quality of our people. We offer a range of benefits designed to support your well-being and work-life balance, including:

    • Competitive salary and annual leave entitlements.
    • Flexible health insurance options tailored to you and your family’s needs.
    • Retirement planning offerings for long-term financial security.
    • Global Employee Assistance Program offering 24/7 support for personal and family well-being.
    • Optional benefits like childcare vouchers, gym memberships, and subsidized travel passes.

    Diversity & Inclusion at ICON

    We believe that diversity, inclusion, and belonging are key to our success. Our rich diversity drives innovation, enabling us to better serve our patients, clients, and communities. ICON is committed to creating an accessible and inclusive environment for all candidates and ensuring a workplace free of discrimination and harassment.

    Interested in the Role?

    If you are passionate about pharmacovigilance and clinical research, and want to contribute to our global mission, we encourage you to apply. Don’t worry if you don’t meet all the requirements – we welcome diverse talents and experiences!

    [Apply here] (Insert application link)
    If you’re a current ICON employee, please apply via the internal portal.

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