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    Local Qualified Person For Pharmacovigilance In Poland

    Iqvia
    4+ years
    Not Disclosed
    Warsaw
    10 Jan. 9, 2025
    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: Local Qualified Person (QP) for Pharmacovigilance - Poland

    Job Overview:
    As a Local Qualified Person (QP) for Pharmacovigilance in Poland, you will act as the designated local QP for customers requiring services related to their medicinal products. This role involves ensuring compliance with regulatory requirements, responding to authority requests, and supporting safety assessments.

    Key Responsibilities:

    • Serve as the local Qualified Person (QP) in line with the requirements outlined in the IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
    • Be available on a 24/7 basis to handle communications from the local Competent Authority (CA), including acting as the primary contact during pharmacovigilance inspections.
    • Address requests from Competent Authorities to assess the benefit-risk profile of medicinal products, including sales data, prescriptions, and post-authorization safety studies.
    • Ensure that your contact details are registered with the Competent Authority at the start of your contract.
    • Stay up to date with changes in local regulatory requirements, ensuring the implementation of risk management plans and safety measures.
    • Develop a strong understanding of project budgets, scope of work (SOW), and maintain project materials, such as files, templates, and databases.
    • Provide regular project updates to the Project Manager, reporting on metrics, changes in SOW, and customer concerns.
    • Communicate monthly updates to the EU QPPV/designee and complete regulatory reports as needed.

    Minimum Education and Experience Requirements:

    • A Bachelor’s degree in life sciences, medicine, pharmacy, nursing, or an equivalent educational background.
    • Approximately 4 years of relevant clinical experience, including experience in clinical trial safety and post-marketing safety, or an equivalent combination of education and experience.
    • Must reside in Poland and be fluent in Polish (at least C2 level).
    • Proficient in English.

    Required Knowledge, Skills, and Abilities:

    • In-depth understanding of global, regional, and local regulatory requirements, including International Conference on Harmonization (ICH) guidelines.
    • Strong knowledge of Poland's pharmacovigilance legal framework.
    • Familiarity with relevant Standard Operating Procedures (SOPs).
    • Excellent written and verbal communication skills.
    • Analytical mindset and ability to interpret safety reports, literature, and manage inspections.
    • Strong organizational and project management abilities.
    • Capability to establish and maintain effective relationships with colleagues, managers, clients, and third parties.
    • Ability to assess and understand the safety profile and benefit-risk balance of medicinal products.
    • Comprehensive understanding of compliance and quality management systems.

    Physical Requirements:

    • Must be available by phone 24/7 to address Competent Authority inquiries.
    • Must be a resident of Poland.

    About IQVIA:
    IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights for the life sciences and healthcare industries. We drive innovation to accelerate the development and commercialization of medical treatments, aiming to improve patient outcomes globally. Learn more at IQVIA Careers.

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