Services in PhV

5. December 2019

As a service provider for Pharmacovigilance activities, we would like to offer you different models for our joint collaboration.

If desired we provide you the complete Pharmacovigilance package.

Furthermore, we are glad to assist you in individual / combinations of routine activities or temporary projects.

Therefore, simply select the services you are looking for:

● Researches
national literature, international literature including MLM, authority websites (EMA, national authorities), publications from relevant committees (e.g. PRAC), Eudravigilance database

● Management of individual case reports
Processing including evaluation, entry in a PV database or EVWEB, electronic submission to authorities

● Signal detection incl. EVDAS

● PSURs incl. E-Submission to the EMA

● RMPs

● PSMF
Creation and maintenance of documents

● Creation and / or update of your PV-SOP system

● Compliance Management
Definition of KPIs and calculation of those

● Position of “Stufenplanbeauftragter” / QPPV

● PV trainings

● xEVMPD

● GVP-Audits (internal/external)

Please don´t hesitate to ask us for your personal model of our cooperation.

As a further model, we offer you to act as marketing authorisation holder. In this case, you remain the owner of the authorization, of course, but you would use the PV-SOP system, the responsible persons and the performance of PV activities of Zicura Pharma Solutions GmbH.