Medimo Oy
Pharmacovigilance
Pharmacovigilance activities are regulated by GVP (Good Pharmacovigilance Practices) and therefore also within the scope of regulatory inspections. That is why it is important that pharmacovigilance system is in order and up to date so that the safety of the medicine can be guaranteed throughout its life cycle.
Pharmacovigilance services – human and veterinary medicines
We provide you with services related to the pharmacovigilance of medicines and medical devices:
Post-marketing
EU qualified person responsible for pharmacovigilance (EU QPPV) services
The marketing authorisation holder for human and veterinary medicines shall have at its disposal a qualified person responsible for pharmacovigilance (QPPV), whose task is to ensure and promote drug safety. Through Medimo, you get an experienced QPPV who knows pharmacovigilance and local legislation.
Acting as a local pharmacovigilance contact person (Finland, Sweden, Denmark, Norway)
We provide you with a qualified and experienced pharmacovigilance contact person for the Finnish, Swedish, Danish, and Norwegian markets. We are familiar with pharmacovigilance and local legislation, and we keep our customers up to date if, for example, there are changes to the legislation.
Literature monitoring from local and global sources
Our services include both global literature monitoring and local literature monitoring (Finland, Sweden, Norway, Denmark).
Establishment and maintenance of the pharmacovigilance system master file (PSMF)
The marketing authorization holder must have one or more pharmacovigilance system master files (PSMF), which describe in detail the pharmacovigilance system for all the marketing authorization holder’s medicinal products. We prepare and maintain the pharmacovigilance system master files appropriately.
Processing of adverse reaction reports
Registration of product information in Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
Electronic reporting of adverse reactions to EudraVigilance
Reconciliation
Translations of adverse reaction reports and other pharmacovigilance documentation
Preparation of periodic safety update reviews (PSUR) or review of a PSUR prepared by the customer
Drafting or revision of standard operating instructions (SOP), work instructions and manuals
Support in signal management process
Risk management and risk minimisation activities
We can take care of all pharmacovigilance activities related to medicines for you in accordance with the EU’s Good Pharmacovigilance Practices (GVP). Contact us – we will get answers to your questions quickly!
