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Qtech-Sol Professional Development Center

Drug Safety-Pharmacovigilance Associate – (DSAT)

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  • Curriculum Overview

    Designed by industry experts for students and young professionals. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.

    DRUG SAFETY-PHARMACOVIGILANCE ASSOCIATE

    LIST OF TOPICS:

    1. Introduction to Clinical Research

    2. Drug Development Process

    3. Introduction to Drug Safety / Pharmacovigilance

    4. Role of DSA / PVA (Trials)

    5. Introduction to Adverse Events

    6. ICH-Good Clinical Practice Guidelines

    7. Drug Safety Regulation and Guidelines

    8. Overview of Clinical Trial Protocol

    9. Characteristics of a Case

    10. Sources of Individual Case Reports

    11. Drug Safety Data Extraction and Pre-Processing

    12. SOP Development

    13. Communication with Cross Functional Team

    14. Understanding 21 CFR Part 11 and HIPAA

    15. Basic of Coding in Drug Safety

    16. Case Follow up approaches and handling of Cases

    17. Clinical Trial Safety Surveillance

    18. Phase IV Trials and Pharmacovigilance

    19. Case Narratives

    20. SAE Reconciliation

    21. Drug Safety Database and Software

    22. Special Scenarios

    EXERCISES

    CASE 1. Introduction to Adverse Events CASE 2. Role of DSA / PVA

    CASE 3. Characteristics of Case

    CASE 4. Medical Record Extraction

    CASE 5. Basics of Coding

    CASE 6. Triage

    CASE 7. Case Narratives

    CASE 8. SAE Reconciliation

    CASE 9. Drug Safety Database and Software

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