Performing the Case Analysis and Peer Review (Quality check)
Perform medical review (including verifying the coding & labeling, reviewing narratives, causality statement, medical aspect of follow-up request), validate follow-up request and perform medical assessment of the case for the Category I and II cases
Prioritize workloads to ensure expedited cases are processed within defined timelines
Responsible for the timely completion of individual cases and meeting the SLA for data entry and case analysis activity as per SOP.
Approval and the locking of Category I cases
Responsible for the timely reception of an individual case on a daily basis.
Responsible for registration in e-logbook and for the duplicate search process.
Ensure quality and timely creation and closure of PV query as per SOP.
Ensure the filing of PV dossier and documents as per the SOP
How Pharmacovigilance team work:
Case processing is not detection of ADR.
It's a processing of ADR reports that the compony receive from various sources. Once the case is received from any source( Telephone, fax, email, licencing agreement, form the regulators or other companies), it is been assigned to the triage team.
It checks the case for 4 valid criteria.
If the case is valid it is being evaluated for its seriousness and expectedness criteria. A unique identity number is assigned to each individual case. Then the case is sent to the safety associate for the data entry.
The work of case processing team starts now.
The safety associate enters the case into safety database; perform MedDRA coding and writing narratives of the case.
In case of any query he/she asks for follow-ups information to the reporter.
After the data entry the case is assigned to the QC team, where the QC person checks the work done by Safety associate.
The case moves in the workflow to the Medical Reviewer (MBBS Doctor) who assesses the case for Medical aspects, performs the causality assessment and gives a company comment on each case.
Now the case is ready for submission to the regulatory authority. The submission team submits the Case to the regulatory authority according to the local requirement.