Various elements required in a Pharmacovigilance Set-up

Data can come from different sources like:

IVRS(Interactive Voice Reporting System),,Patient registries,,Clinics,,CRO, Letters, Press, Sales contacts;

Literature, Calls, Company, Customers web forums/sites, Databanks, Reports, Journals, Emails.
Pharmacovigilance team is involved in collecting data related to

• Clinical Trails data
• Adverse events
• Complaints
• Product related info

The cases are processed in the following fashion:

Data entry/Coding/Medical review: The safety data is prepared and then submitted to the respective regulatory authority.