- Key Accountabilities:
-Introduction to clinical research
-Fundamentals of Pharmacovigilance
-Regulations in Pharmacovigilance: FDA, ICH
-Adverse events and its types
-Different sources of Adverse events reporting
-Different types of AE reporting forms
-Expedited reporting and its timelines
-Different departments working on Pharmacovigilance
-Roles and responsibilities of case receipt unit
-Four factors for the reportable case
-Seriousness criteria of adverse event
-Expectedness or Listedness of adverse event
-Causality assessment of the adverse event
-Triage of cases
-Forms used: AERS, Medwatch, CIOMS
-Document management/privacy/follow-up information obtaining and -documenting for ICSRs
-Database overview & database usage
-Identifying a valid case and case processing
-Pharmacoviligance event ranking/using the always serious list/rush cases card/upgrading serious to non-serious, and non-serious to serious case --.Unifying a diagnosis/lack of effect/event identification and upgrading adverse events/co-licensing partner process
- Multiple suspect products/drug interaction/overdose
-Medical review process
MedDRA coding andWHODD
Exercise for MedDRAcoding practice
-Line listing/PSURs/SUSAR processing
-Case quality check, Medical review and its submission.
-Narrative Writing
-Exercises and practicing with writing narratives
-Overall workflow of a drug safety associate
-Line listing/PSURs/SUSAR processing
-Case quality check, Medical review and its submission.
-Narrative Writing
-Exercises and practicing with writing narratives
-Overall workflow of a drug safety associate
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