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    Qualified Person Responsible For Pharmacovigilance (Qppv) In The Eu And Uk (Homebased)

    Primevigilance
    0-1 years
    Not Disclosed
    Croatia Remote - Europe Zagreb
    10 Dec. 6, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Qualified Person Responsible for Pharmacovigilance (QPPV)
    Location: Home-based (EU and UK)
    Employment Type: Full-time
    Department: QPPV Department

    Company Overview:

    PrimeVigilance, part of Ergomed PLC, is a specialized mid-sized provider of pharmacovigilance services, founded in 2008. With teams across Europe, North America, and Asia, we deliver high-quality support in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance to pharmaceutical and biotechnology companies of all sizes.

    Our mission is to make a positive impact on patients' lives by fostering long-term partnerships with our clients, offering expert services across various therapeutic areas, including medical devices.

    PrimeVigilance values employee well-being, providing excellent training, professional development opportunities, and promoting a healthy work-life balance.

    Job Description:

    As the EU QPPV, you will ensure compliance with pharmacovigilance (PV) requirements by maintaining oversight of the company's PV systems and safety profiles for its medicinal products.

    Key Responsibilities:

    1. Establish and Maintain PV Systems:

      • Collect and collate reports of all suspected adverse reactions, ensuring data is accessible within the EU community.

    2. Regulatory Communication:

      • Respond to Competent Authority (CA) requests for additional information on benefit-risk evaluations promptly.
      • Provide relevant information on planned post-authorization safety studies to CAs.

    3. Continuous Availability:

      • Serve as a primary point of contact for CAs, the European Medicines Agency (EMA), and the Marketing Authorization Holder (MAH).
      • Ensure backup procedures are in place to maintain availability.

    4. Safety Oversight:

      • Maintain an overview of safety profiles, emerging concerns, and commitments related to product safety and use.
      • Monitor findings from studies and programs conducted by the company.

    5. Leadership and Collaboration:

      • Guide teams in maintaining compliance with global PV regulations and standards.
      • Support audits and inspections, ensuring the PV system meets quality expectations.

    Qualifications:

    • Educational Background:

      • Degree in Life Sciences, preferably Medicine (human or veterinary) or Pharmacy.

    • Knowledge & Skills:

      • Strong understanding of PV system operations and global regulations.
      • Familiarity with standards and best practices for safety processing, reporting, and surveillance.
      • Demonstrated experience in leading PV projects or teams.
      • Solid managerial and operational skills.

    • Experience:

      • Proven track record in pharmacovigilance roles, including profound experience as QPPV.

    • Language Proficiency:

      • Excellent written and spoken English communication skills.

    Why Join PrimeVigilance?

    Employee-Centric Approach:

    We prioritize diversity, equity, and inclusion by fostering a collaborative, human-centric workplace that celebrates cultural diversity and individuality.

    Development Opportunities:

    • Comprehensive training programs.
    • Career development paths tailored to personal and professional growth.

    Global Collaboration:

    • Work with a multicultural team worldwide, with English as the company language.

    Supportive Environment:

    • Friendly, inclusive, and supportive workplace culture.

    Core Values:

    • Quality
    • Integrity & Trust
    • Drive & Passion
    • Agility & Responsiveness
    • Belonging
    • Collaborative Partnerships

    If our mission and values align with your aspirations, we welcome your application to join PrimeVigilance in delivering excellence and making a meaningful difference in healthcare!

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