Pharmacovigilance is all the activities finalized for identifying, evaluating, understanding and preventing adverse effects correlated with the use of medicines, with the aim of assuring a favourable benefit/risk relationship for the users.
SCF offers to its clients a complete management in outsourcing of the service of pharmacovigilance, through the certified Qualified Person for European Pharmacovigilance (EU-QPPV), to carry out all the activity that a pharmaceutical company has to guarantee, to be compliant with the pharmacovigilance legislation in force, through the implementation of:
- a management system for the quality of Pharmacovigilance and relative Standard Operating Procedure (SOP),
- Periodic Safety Update Reports (PSUR),
- Risk Management Plan (RMP),
- Activity of monitoring of the National Pharmacovigilance Network (RNF) as referring company,
- Monitoring of national and international scientific literature for medical products and active substances,
- Preparation, maintenance and updating of the Pharmacovigilance System Master File (PSMF),
- Management of the Safety Reports in Eudravigilance,
- Updating of medical products in the European database Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
- Taking on the role of Local contact point,
- Planning, conduction and reporting of Pharmacovigilance audit and relative management and planning of corrective and preventative actions from an audit.
- Manuale di qualità e relative SOP:
- Piano di gestione dei rischi (RMP);
- Gestione dei rapporti con l’ente di certificazione;
- Assistenza in corso di audit.
Moreover, pharmacovigilance activities could be performed also during the conduction of clinical studies through: