Global Pharmacovigilance activities are undertaken by the Pharmacovigilance Department (PVD) of Medical Affairs at Gedeon Richter Plc. in Budapest.

The PVD consists of the following five units:

• QPPV Office--- QPPV oversight of the Richter Group PVS, supervision of PV training, crisis management

• Global Pharmacovigilance Unit--- global coordination-communication-support, PV agreements, ARISg, Medical Information Service (MISS)
  
  
  

  The QPPV Office and the Global Pharmacovigilance unit also serve global functions by connecting the Budapest PVD with all members of the Gedeon Richter Group where pharmacovigilance activities are carried out. These include:

-         QPPVs of EU subsidiaries (Gedeon Richter Romania and GZF Polfa)

-        PV contact persons of Richter Representative Offices, who are responsible for pharmacovigilance in their own territories

-          PV contact persons of the commercial subsidiaries

• Postmarketing Pharmacovigilance Unit--- spontaneous case handling, literature screening, case processing, expedited report, compliance metrics

• PSUR Unit--- PSUR scheduling, data collection, PSUR compilation WF, PSUR quality control, submission tracking, PSUR compliance metrics

• Clinical Pharmacovigilance Unit--- clinical trial PV support, SUSAR (suspected unexpected serious adverse reaction) handling, CT documentation, IB, contracts, CRO connections, Safety Board, benefit-risk assessment