A 5.5 years of experience in the field of Pharmacovigilance combine
resourcefulness and problem-solving skills with clinical knowledge to consistently deliver
improved ethical research and productive results. I have handled Individual Case
Safety Reports Activities of Case Review Peer Review Quality Control and Acting Team
lead.
As per case prioritization status in the dedicated work list, access the allocated case
and source documents.
• As per conventions defined in user guide completes data entry within the Global
Safety database as appropriate.
• Ensures WHO Drug Dictionary and MedDRA coding of applicable fields.
• For LAM cases, if the case must be downgraded or upgraded during the case
processing: Assign an action item ‘CEN Case Upgrade/Downgrade’ to the concerned
LSO, for Literature cases received via LAM, the Action Item should be assigned to
the Global Literature Team and for cases received via Email and E2B, re
acknowledgement to be sent the via email.
• Prepare a Case narrative for each Case, which reflects the safety data.
• Perform validation of the data (E2B check) for each case and make any corrections as
needed.
• Check overall consistency and typo, makes the necessary correction, if applicable.
• Checks pending action items ensures resolution and closes the action items for the
case.
• Performs duplication of cases in specific situations.