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QPPV in outsourcing

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);
  • Assunzione del ruolo di Local contact point;
  • Planning, conduction and reporting of Pharmacovigilance audit and relative management and planning of corrective and preventative actions from an audit.

Moreover, pharmacovigilance activities could be performed also during the conduction of clinical studies through:

  • Preparation of the specific SOP,
  • Full-time receiving and reporting of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) through Eudravigilance,
  • Preparation and transmission to the competent authorities of the Developed Safety Update Reports (DSUR).