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Qtech-Sol Professional Development Center

Drug Safety-Pharmacovigilance Data Management (DSPM)

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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 DATA MANAGEMENT

    ADVANCED DRUG SAFETY TOPICS

    1. Medical Record Extraction

    2. Adverse Events Case Processing

    3. CIOMS Line Listing

    4. Case processing and FDA Reporting

    for Medical Devices

    5. Revision of SOP Quality Control

    Procedure

    6. SAE Reconciliation

    7. PSUR - Periodic Safety Update

    Reporting

    8. Triage

    9. Data Entry

    10. Signal Detection

    11. Labeling Edit check

    12. Quality Control Procedure

    13. Resolution of queries of pending cases

    14. SUSAR - Suspected Unexpected

    Serious Adverse Reaction

    DRUG SAFETY DATA MANAGEMENT

    15. Introduction to MedDRA

    16. MedDRA Coding Guidelines- Modules 1 thru 4

    17. AE Causality assessments

    18. Introduction to Risk Management Plan (RMP)

    19. Introduction to Risk Management Plan (REMS)

    20. Argus Safety End-User Training Modules 1 thru 6

    21. Product Technical / Quality Complaints (PTC / PQC)

    22. Corrective and Preventative Actions (CAPAs)

    23. Overview of Aggregate Reporting (PSUR/ PBRER)

    24. Overview of Aggregate Reporting - PRAC / DSUR

    EXERCISES

    1. Medical Record Extraction.

    2. Adverse Events Case Processing

    3. CIOMS Line Listing

    4. Case processing and FDA Reporting for Medical Devices

    5. Revision of SOP

    6. Quality Control Procedure

    7. SAE Reconciliation

    8. Triage

    9. Data Entry

    10. Signal Detection

    11. Labeling Edit check

    12. Quality Control Procedure

    13. Resolution of queries of pending cases

    14. SUSAR - Suspected Unexpected Serious Adverse Reaction

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