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    Pharmacovigilance Information Specialist Gpio (Pvis)

    Parexel
    3+ years
    Not Disclosed
    Remote - Europe
    10 July 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, 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)

    Company: Parexel
    Location: Dublin, Ireland (Office-based)

    Overview:

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

    Key Responsibilities:

    • Regulatory Intelligence: Research and maintain drug and device safety reporting regulations, ensuring compliance with relevant laws and guidelines.
    • Country Safety Requirements: Review and update country-specific safety requirements, assist with quality control, and act as a backup for team members.
    • Communication: Liaise with Regulatory Authorities, Ethics Committees, and local safety contacts to obtain safety regulatory updates.
    • Database Management: Update relevant databases, repositories, trackers, and logs in accordance with SOPs.
    • Query Response: Respond to queries regarding safety reporting requirements.
    • Team Collaboration: Assist the GPIO team in daily operations and participate in internal and external meetings as needed.
    • Compliance & Quality: Ensure work meets the requirements of Service Level Agreements and Key Performance Indicators, focusing on quality, compliance, and training.
    • Expertise Provision: Provide functional expertise on safety reporting requirements to Pharmacovigilance Operations staff in both pre and post-marketing settings.
    • Audit Participation: Prepare for and respond to internal/external audits and inspections.
    • Knowledge Maintenance: Stay updated on relevant regulations and internal SOPs.
    • Additional Duties: Perform other tasks as required by management.

    Required Skills:

    • Regulatory Knowledge: Strong understanding of expedited and periodic drug safety reports required by Regulatory Authorities, Ethics Committees, and Investigators.
    • Drug Development: Knowledge of the drug development process.
    • Regulation Interpretation: Ability to interpret and apply global safety regulations.
    • Research Skills: Experience in reading and researching legislation and guidance documents.
    • Communication: Excellent verbal and written communication skills, with strong presentation abilities.
    • Analytical Skills: Strong analytical and problem-solving capabilities.
    • Interpersonal Skills: Excellent interpersonal and organizational skills, with the ability to prioritize tasks effectively.
    • Team Collaboration: Ability to work collaboratively in a team environment.
    • Client Focus: Strong client-focused approach to work.
    • Technical Proficiency: Experience with computer applications, including database management.

    Qualifications:

    • Education: Degree in Pharmacy, Nursing, Life Science, or a related health field, or equivalent work experience.
    • Experience: Preferably experience in reporting expedited or periodic safety reports to Regulatory Authorities/Ethics Committees or Investigators, or experience with safety report processing in a safety database. Experience in clinical trials or post-market drug safety projects is also valued.

    Other Requirements:

    • Adaptability: Willingness to take on additional tasks as required by management.
    • Commitment to Learning: Maintaining up-to-date knowledge of relevant regulations and SOPs.

    This position offers an opportunity to work in a dynamic environment, contributing to the safety and efficacy of healthcare products globally.

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