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    Pharmacovigilance Local Contact Person With Hungarian And English Language

    Iqvia
    2+ years
    Not Disclosed
    Budapest
    10 Nov. 6, 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, 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: Pharmacovigilance Local Contact Person (Qualified Person)

    Location: Hungary

    Company: IQVIA

    Overview: As the Pharmacovigilance Local Contact Person, you will serve as the Local Qualified Person (QP) for customers requiring pharmacovigilance services for their medicinal products. You will ensure compliance with regulatory requirements and serve as a vital contact point for the Competent Authorities in Hungary.

    Responsibilities:

    • Act as the local Qualified Person in compliance with the IQVIA Lifecycle Safety Regulatory Intelligence Database (RID) requirements.
    • 24/7 availability to receive calls from the Competent Authority as needed.
    • Serve as the primary contact for pharmacovigilance inspections, directly engaging with Competent Authority inspectors during statutory inspections.
    • Respond promptly and thoroughly to requests from Competent Authorities for post-marketing safety evaluations, including sales data, prescriptions, and safety studies.
    • Ensure that your name and contact details are registered with the Competent Authority at the start of the contract.
    • Stay up-to-date with local regulatory changes, ensuring that risk management plans and safety mechanisms are in place.
    • Maintain an in-depth understanding of each project's budget and scope of work (SOW), ensuring proper project documentation, files, forms, templates, and workflows.
    • Provide regular reports to the project manager on project metrics, SOW changes, and customer concerns.
    • Communicate monthly updates to the EU QPPV/designee and complete regulatory reports as required.

    Minimum Required Education and Experience:

    • Bachelor’s degree in life sciences, medicine, pharmacy, nursing, or a related field.
    • At least 2 years of relevant experience, including clinical trial safety and post-marketing safety management.
    • Fluent in Hungarian (C2 level).
    • Excellent command of English (C1 level).
    • Deep knowledge of global, regional, and local regulatory requirements in pharmacovigilance (especially within the EU and Hungary).
    • Solid understanding of Standard Operating Procedures (SOPs) and compliance with pharmacovigilance regulations.
    • Ability to maintain an overview of a product’s safety profile and its benefit/risk balance.
    • Availability by phone 24/7 for Competent Authority inquiries.

    Company Overview: IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. Our mission is to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and public health.

    Learn more about opportunities at IQVIA: IQVIA Careers

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