Case Processing Lifecyle in Pharmacovigilance

[@shashankrevankar6623]

Thank you 🙏

[@shraddhayadav8118]

Thank you sir...its very useful👍

[@sandeepkrishnap]

Please make a video on reconciliation topic- sae and post marketing (Safety-quality defect reconciliation, partner case reconciliation (market research, specialty pharmacy providers, vendors)

[@VigiServeAcademy]

Good idea.. Thanks

[@sivamuchinthala7533]

@@VigiServeAcademy any videos on SAE reconciliation please

[@rahinshaikh811]

Thank you sir, i have a question, actually i have taken admission for clinical research i am graduated in paramedics and also working as Radiology technician, and having 4yrs of experience too. Now i have more interest in getting into MedDRA, how can I do that? Is there any scope for candidates like me

[@sandeepkrishnap]

How would cases identified as a miss or discrepancy during a reconciliation activity be handled? Would they be submitted as late case to the authorities?

[@VigiServeAcademy]

Yes, you need to record a deviation first and then undertake the late submission

[@sandeepkrishnap]

Thank you!

[@harpreetjassal734]

How CP is different in CT and post marketing cases?

[@VigiServeAcademy]

The post-marketing reports are generally the non-solicited ones, where the data may not be structured at times or even be incomplete. However, CT case-reports are solicited ones where the company has complete oversight and even access to the healthcare professionals

[@kavinmahalingam2617]

What is labelling mean here for case processing sir?

[@VigiServeAcademy]

To check if an adverse event is expected to happen with a drug or not - Such documents are the labelling docs (e.g., package insert)

[@013pratikshakamble4]

What is process associate in BPO in Pharmacovigilance??? Is it not CASE PROSSESING???

[@VigiServeAcademy]

A process associate in a BPO may even be involved in Case Processing

[@013pratikshakamble4]

@@VigiServeAcademyTHEN what is exact role of process associate in PV??

[@VigiServeAcademy]

That varies from company to company and depends on the scope of activities undertaken by the company. E.g., some process associates are only involved in literature search, some in data entry, some in Safety compliance, and so on!