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    Pharmacovigilance Training Course

    BY
    Henry Harvin

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    Mode

    Online

    Duration

    18 Hours

    Quick Facts

    particular details
    Medium of instructions English
    Mode of learning Self study
    Mode of Delivery Video and Text Based

    Course and certificate fees

    certificate availability

    Yes

    certificate providing authority

    Henry Harvin

    The syllabus

    Module 1: Introduction of Pharmacovigilance

    • Overview Of Pharmacovigilance
    • Standard Terms And Terminology In Pharmacovigilance

    Module 2: Medical Evaluation of Adverse Events in Pharmacovigilance

    • Adverse Event Reporting System
    • Form Adverse Event Reporting System
    • Diagnosis And Management Of ADRs
    • Medical Evaluation Of AE

    Module 3: Case Processing

    • Global Perspective Of Pharmacovigilance
    • Single Case Processing
    • Case Narrative Writing

    Module 4: Pharmacovigilance Reporting Database, Signal Detection, Management, and Risk Assessments & Evaluation

    • Quality System In PV
    • Expedited Reporting Criteria
    • PSUR & PBRERPV
    • Database And Signal Detection
    • Risk Assessments & Managements

    Module 5: Medical Dictionary for Regulatory Activities Meddra

    • MedDRA

    Module 6: PV Laws and Guidlines

    • Regulatory Guideline
    • Laws In PV
    • SOPS In PV
    • PV Auditing And Inspection
    • Regulatory Aspects In PV

    Complementary Module 1: Soft Skills Development

    • Business Communication
    • Preparation for the Interview
    • Presentation Skills

    Complimentary Module 2: Resume Writing

    • Resume Writing Techniques

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