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    Pharmacovigilance Information Specialist Gpio (Pvis)

    Parexel
    1-5 years
    Not Disclosed
    Dublin
    10 July 1, 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, 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 Description: Pharmacovigilance Information Specialist (PVIS)

    Location: Dublin, Ireland (Parexel Office)

    Overview: Parexel is seeking a Pharmacovigilance Information Specialist (PVIS) for the Global Pharmacovigilance Information Office (GPIO) based in Dublin, Ireland. 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:

    • Research and Maintenance:
      • Research and maintain drug and device safety reporting related regulatory intelligence.
      • Perform country safety requirement reviews and updates for assigned countries.
      • Support team members with quality control (QC) of country reviews and act as a backup for other team members as needed.
    • Liaison and Communication:
      • Communicate with Regulatory Authorities, Ethics Committees, local safety contacts, etc., to obtain relevant safety regulatory updates.
      • Update relevant databases, repositories, trackers, and logs on an ongoing basis as per relevant SOPs.
      • Respond to questions and queries regarding safety reporting requirements as per relevant SOPs.
    • Collaboration and Support:
      • Collaborate with and assist the GPIO team in daily operational activities.
      • Participate in functional internal and external team meetings as needed.
      • Ensure work meets requirements outlined in Service Level Agreements and achieve all defined Key Performance Indicators (KPIs) in terms of quality, compliance, and training for regulatory intelligence.
      • Provide functional expertise and oversight of safety reporting requirements to PV Operations staff (both pre and post-marketing).
      • Prepare for, participate in, and respond to internal/external audits and inspections as needed.
    • Regulatory Knowledge:
      • Maintain up-to-date knowledge of relevant regulations and client and Parexel's SOPs.
      • Perform other tasks as required by management.

    Skills and Qualifications:

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

    Experience:

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

    Education:

    • Degree in Pharmacy, Nursing, Life Science, or another health-related field, or equivalent qualification/work experience.
    • Associates/diploma degree in any of the above with appropriate work experience may also be considered.

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