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    Pharmacovigilance Information Specialist Gpio (Pvis)

    Parexel
    1-5 years
    Not Disclosed
    Remote, USA
    10 July 23, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 This Role

    Job Description:

    Parexel is seeking a Pharmacovigilance Information Specialist (PVIS) for the Global Pharmacovigilance Information Office (GPIO) based in the Dublin, Ireland office. This role involves researching, reviewing, and maintaining information related to expedited and periodic safety reporting requirements for both clinical trial studies and post-market projects. The PVIS ensures company and client compliance with relevant national and regional drug/device safety regulations and Standard Operating Procedures (SOPs).

    Responsibilities:

    • Regulatory Intelligence: Research and maintain drug and device safety reporting-related regulatory intelligence.
    • Country Reviews: Conduct safety requirement reviews and updates for assigned countries, support team members with quality control of country reviews, and act as a backup for other team members as needed.
    • Communication: Liaise with Regulatory Authorities, Ethics committees, local safety contacts, etc., to obtain updates relevant to safety reporting.
    • Database Management: Update relevant databases, repositories, trackers, and logs on an ongoing basis according to SOPs.
    • Query Response: Respond to questions and queries regarding safety reporting requirements as per SOPs.
    • Operational Support: Collaborate with and assist the GPIO team in day-to-day activities.
    • Meetings: Participate in functional internal and external team meetings as needed.
    • Compliance: Ensure work meets Service Level Agreements and achieve all defined Key Performance Indicators in terms of quality, compliance, and training for regulatory intelligence.
    • Expertise: Provide functional expertise/oversight of safety reporting requirements to PV Operations staff in both pre and post-marketing settings.
    • Audits and Inspections: Prepare for, participate in, and respond to internal/external audits/inspections as needed.
    • Knowledge Maintenance: Stay up-to-date with relevant regulations and Parexel’s and clients’ SOPs.
    • Additional Tasks: Perform other tasks as required by management.

    Skills:

    • Regulatory Knowledge: Strong knowledge of expedited and periodic drug safety reports required by Regulatory Authorities, Ethics Committees, and Investigators.
    • Drug Development: Understanding of the drug development process.
    • Global Regulations: Ability to interpret and apply global safety regulations.
    • Legislation Research: Experience in reading and researching legislation and guidance documents.
    • Communication: Strong presentation, verbal, and written communication skills.
    • Problem-Solving: Analytical and problem-solving skills.
    • Interpersonal Skills: Excellent interpersonal skills.
    • Organization: Strong organizational and prioritization skills.
    • Team Collaboration: Ability to work collaboratively and effectively in a team environment.
    • Client Focus: Client-focused approach to work.
    • Technical Proficiency: Experience with computer applications, including database management.

    Knowledge and Experience:

    • Experience in reporting expedited or periodic safety reports to Regulatory Authorities, Ethics Committees, or Investigators, or experience with processing safety reports in a safety database.
    • Experience with clinical trial or post-market drug safety studies/projects.

    Education:

    • Degree in Pharmacy, Nursing, Life Science, or another health-related field, or equivalent qualification/work experience.
    • Associate’s/diploma degree in any of the above with appropriate work experience.

    This revision maintains the original details while improving clarity and readability, ensuring the key responsibilities and qualifications are highlighted effectively

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