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    Local Qualified Person For Pharmacovigilance In Poland

    Iqvia
    0-4 years
    Not Disclosed
    Poland Warsaw
    10 Jan. 21, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm and LifeScience Graduates 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 for Pharmacovigilance in Poland
    Employer: IQVIA
    Location: Warsaw, Poland
    Start Date: 7th January 2025
    Closing Date: 6th February 2025

    Job Overview:

    IQVIA is seeking a Local Qualified Person for Pharmacovigilance in Poland to serve as the local QP for customers requiring pharmacovigilance services for their products. The successful candidate will be responsible for ensuring compliance with regulatory requirements and managing safety-related activities for medicinal products.

    Key Responsibilities:

    • Regulatory Compliance: Act as the local Qualified Person (QP) in accordance with IQVIA’s Lifecycle Safety Regulatory Intelligence Database (RID).
    • Competent Authority Liaison: Be available on a 24/7 basis to respond to calls from the local Competent Authority. Serve as the point of contact for pharmacovigilance inspections and directly engage with Competent Authority inspectors during statutory inspections.
    • Regulatory Requests: Respond promptly to requests from Competent Authorities regarding the evaluation of the benefits and risks of medicinal products, including sales, prescriptions, or post-authorization safety studies.
    • Notification: Ensure that your name and contact details are provided to the Competent Authority upon contract commencement.
    • Regulatory Awareness: Stay up-to-date with local regulatory requirements and ensure that safety measures and risk management plans are in place and followed.
    • Project Management: Establish and maintain an understanding of each project’s budget and scope of work (SOW), and manage project materials, such as project files, templates, and databases.
    • Reporting: Provide regular updates to the project manager on project metrics, SOW changes, customer concerns, and requests. Communicate monthly updates to the EU QPPV/designee and complete regulatory reports as required.

    Minimum Required Education and Experience:

    • Education: Bachelor’s degree in life sciences, medicine, pharmacy, nursing, or an equivalent field.
    • Experience: Approximately 4 years of relevant clinical experience, including managing clinical trial safety and post-marketing safety, or an equivalent combination of education, training, and experience.
    • Language Skills: Fluent in Polish (C2 level) and excellent command of English.

    Required Knowledge, Skills, and Abilities:

    • Regulatory Knowledge: In-depth knowledge of global, regional, and local regulatory requirements, including International Conference on Harmonization (ICH) guidelines.
    • Pharmacovigilance Expertise: Solid knowledge of the pharmacovigilance legal framework in Poland and relevant Standard Operating Procedures (SOPs).
    • Communication Skills: Excellent written and verbal communication skills.
    • Analytical Skills: Strong analytical and problem-solving skills when interpreting safety reports, literature, and inspections.
    • Organizational Skills: Strong organizational and project management abilities.
    • Interpersonal Skills: Ability to build and maintain effective working relationships with colleagues, managers, customers, and third parties.
    • Safety Profile Awareness: Maintain an overview of the product's safety profile and the factors affecting its benefit-risk balance.
    • Compliance Knowledge: Understand compliance requirements and quality management systems.

    Physical Requirements:

    • Availability: Must be available 24/7 for Competent Authority enquiries.
    • Residency: Must be a resident of Poland.

    About IQVIA:

    IQVIA is a global leader in providing clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We accelerate the development and commercialization of innovative medical treatments to improve patient outcomes worldwide.

    For more information about IQVIA, visit: IQVIA Careers.

    Closing Date for Applications: 6th February 2025

     

     

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