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Qtech-Sol Professional Development Center

Advanced Drug Safety Associate (ADSA)

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  • Curriculum Overview:

    The course provides a thorough Foundation, Advanced and Project Management related concepts focusing clinical trials, drug development, Study design, Project Management, and Quality Assurance concepts towards Drug Safety in reference to roles and responsibilities performed by Drug Safety / Pharmacovigilance Associate. Core topics includes Role of DSA (Trials), Clinical Trial Safety Surveillance, Phase IV Trials and Pharmacovigilance, Introduction to Adverse Events, SAE Reconciliation, Characteristics of a Case, Sources of Individual Case Reports, Basics of Coding in Drug Safety, Case Narratives, Medical Review, Case Follow-up Approaches and Handling of Cases, MedDRA and Argus reporting, Drug Safety Data Extraction and Pre-processing. The course curriculum is designed to give an edge to obtain job opportunity in Drug Safety / Pharmacovigilance field.

    ADVANCED DRUG SAFETY ASSOCIATE

    LIST OF 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

    What is the Difference Between DSA and Advanced DSA Training?

    DSA Basic and core topics and exercises Certain educational background is strongly recommended to enter the industry Designed for non-experienced individuals to enter into field in depth knowledge of roles and responsibilities of DSA plus theoretical aspect with projects which help to understand industry requirements

    ADSA Advanced topics and exercises Prior training or relevant experience is required Designed for experienced professionals to add new skills set Exposure to diverse DSA exercises, real time documentation Plus advanced learning supported by practical case scenario tasks and follow up process

     

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