Adverse Event Follow-Up
In addition to identifying and reporting initial information on spontaneous adverse events, Professional Information is able to perform follow up with the reporter to obtain additional information on behalf of the Pharmacovigilance (PV) Department.
Medical Information is usually the first port of call for reporting spontaneous adverse events. However, the reporter often has inadequate time or information available at the first contact to provide full data on the adverse event. A robust follow up process is therefore essential, but this is the administrative part of the PV process which can be time consuming and resource intensive.
Follow-up is carried out using standard follow-up letter templates and/or by telephone depending on the service specifications agreed with the client.
The entire process is governed by a Working Practice which is agreed between Professional Information and the client prior to service commencement to ensure that the service meets client expectations, complies with client SOPs, and is fully documented for pharmacovigilance audit purposes.
