Pharmacovigilance System Master File (PSMF)
You will probably have heard of this since you landed on a PV company website. Pharmacovigilance System Master File (PSMF) is the one guiding document defining your entire PV system in EU. It describes all processes and structures the MAH has in place to ensure compliance with GvP and EU legislation. You’ll need to maintain and update the document regularly in order to run your PV operations, and upon request, make available to regulatory agencies for review.
When you’re applying for a Marketing Authorization, you’ll need to provide a summary of the PSMF. Best to put the document together prior to submitting the MA application. As part of the summary, you will name your European Union Qualified Person for Pharmacovigilance. Typically, the PSMF shall be located where the EU QPPV resides (or alternatively, at the location where PV activities are performed).
Similar to your signal management activities, as you monitor the evolution of your product(s) safety profile, you should evaluate any new safety information in a periodic aggregate report.
In the EU and in many other countries, this is called Period Safety Update Report and it should include an aggregate info on all safety relevant information in a given time period. The frequency largely depends on how new the product is.