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    Pharmacovigilance Physician Ii - Endocrincology Experience

    Primevigilance
    2+ years
    Not Disclosed
    Croatia 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: Pharmacovigilance Physician II – Endocrinology Experience
    Location: Remote
    Employment Type: Full-time
    Department: PV Medical Group

    Company Overview:

    PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. We pride ourselves on consistent global growth, offering expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

    With staff located across Europe, North America, and Asia, we support pharmaceutical and biotechnology partners of all sizes across a wide range of therapeutic areas, including medical devices. PrimeVigilance fosters a healthy work-life balance, offering a supportive environment, extensive training, and opportunities for professional growth.

    Job Description:

    The Pharmacovigilance (PV) Physician II is responsible for advanced medical review, signal detection, and aggregate reporting. With endocrinology experience, the role includes mentoring junior staff, supporting QPPV functions, and providing strategic input into pharmacovigilance processes.

    Key Responsibilities:

    Client-Specific Responsibilities:

    1. Case Management:

      • Review and approve ICSRs and Serious Adverse Event (SAE) reports, including causality assessments, seriousness, and company comments.
      • Maintain adverse event trackers and other required documentation.

    2. Risk Management and Regulatory Support:

      • Contribute to Risk Management Plans (RMPs) and Periodic/Development Safety Update Reports (PSURs/DSURs).
      • Prepare responses to regulatory authority requests and participate in regulatory compliance activities.

    3. Signal Detection and Benefit-Risk Evaluation:

      • Conduct signal detection activities, including reviewing line listings, preparing reports, and categorizing signals.
      • Support clients in benefit-risk assessments and risk minimization strategies.

    4. Strategic Collaboration:

      • Serve on client advisory and scientific committees.
      • Act as EEA QPPV or Deputy for up to two clients, if required.

    Company Responsibilities:

    1. Training and Mentoring:

      • Mentor and train junior PV Physicians.
      • Support the development of company procedures related to pharmacovigilance and signal detection.

    2. Operational Excellence:

      • Provide medical advice to project teams.
      • Act as a company lead for pharmacovigilance initiatives, such as preparing reference safety information (e.g., Company Core Data Sheets).

    3. Quality Assurance:

      • Oversee the quality of signal detection activities and provide compliance metrics to the Quality Department.
      • Contribute to the preparation of signaling-related procedures.

    Qualifications:

    • Medical Qualification:

      • Must be a licensed physician with clinical experience in endocrinology and demonstrated expertise in pharmacovigilance.

    • Technical Skills:

      • Proven ability to assess causality, seriousness, and benefit-risk profiles.
      • Familiarity with aggregate safety reports and signal detection activities.

    • Interpersonal and Organizational Skills:

      • Strong ability to plan, prioritize, and execute multiple tasks.
      • Excellent communication and presentation skills.
      • Team-oriented mindset with cross-cultural and cross-functional collaboration abilities.

    Why Join PrimeVigilance?

    Employee-Centric Culture:

    We foster a workplace that values diversity, equity, and inclusion, ensuring all employees have opportunities to grow and contribute.

    Growth Opportunities:

    • Comprehensive training and career development programs.
    • Opportunities to work on cutting-edge pharmacovigilance projects.

    Global Collaboration:

    • Work with a team of experts worldwide, with English as the primary language.

    Supportive Environment:

    • Friendly and inclusive workplace culture promoting teamwork and innovation.

    Core Values:

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

    If you are a qualified physician with endocrinology expertise and share our values, we invite you to join our mission to improve patient safety and healthcare outcomes globally. Apply now to be part of our innovative team!

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