The Pharmacovigilance System Master File (PSMF) is the most important document within a PV department. It must provide a perfect overview of the Pharmacovigilance system and is always reviewed and assessed during audits and inspections.
We can support you in the preparation and maintenance of your personalised PSMF in line with GVP requirements.
Due to globalisation and the new models of commercial agreements within the Pharmaceutical Industry, the Pharmacovigilance Agreements (Safety Data Exchange Agreements or SDEAs) are increasingly important.
Let us know if you need support to prepare or maintain your SDEAs with partners and affiliates.
WHAT DO WE OFFER
Pharmacovigilance Quality system
The importance of Pharmacovigilance activities means that the MAHs have to implement many quality measures to ensure the compliance and suitability of their PV system.
Azierta gives advice and support in the creation of your Quality System in Pharmacovigilance, including:
PV Compliance: Metric and KPIs
Standard Operating Procedures
Do You Need Assistance?
Contact Our Experts
Just send us your questions & we will give you the help you need.