Syllabus – Pharmacovigilance & Medical/Scientific Writings

PHARMACOVIGILANCE
  • Introduction of PharmacovigilanceOverview Of Pharmacovigilance
    Standard Terms And Terminology In Pharmacovigilance
  • Medical Evaluation Of Adverse Events In Pharmacovigilance Adverse Event Reporting System And Form
    Diagnosis And Managements Of ADRs
    Medical Evaluation Of AEP
  • Case ProcessingGlobal Perspective Of Pharmacovigilance
    Single Case Processing
    Case Narrative Writing
  • Pharmacovigilance Reporting Database , Signal Detection , Managements And Risk Assessments & EvaluationQuality System In PV
    Expedited Reporting Criteria
    PSUR & PBRER
    PV Database And Signal Detection
    Risk Assessments & Management
  • Medical Dictionary For Regulatory Activities medDRAmedDRA
  • PV laws And GuidelineRegulatory Guideline @ Laws In PV
    SOPS In PV
    PV Auditing And Inspection
    Regulatory Aspects In PV
  • MEDICAL/SCIENTIFIC WRITINGDisease management
    Continuing education and training
    Medical reference and information-gathering
    Practice management and monitoring
    Correct spelling, grammar, and punctuation errors
    Copyedit to make writing accurate, clear, and smoothly flowing
    Ensure correct and consistent data across texts and graphics
    Ensure that the content and its organization comply with the appropriate guidelines and standards