Pharmacovigilance
We offer to our customers elaboration of Pharmacovigilance system from basis to further system management. Actually, we provide customers with monitoring of over 280 medicinal products and 250 active substances, what make us a leading company in this area in Poland.
We ensure comprehensive services in accordance with Polish law and EU guidelines, i.e.:
- Preparation of Periodic Safety Update Reports (PSUR) with clinical expert assesment
- Detailed description of Pharmacovigilance system
- Preparation of essential procedures and operating instructions
- Staff training in the scope of Pharmacovigilance, provided in premises of the cooperation company
- Record-keeping of all case reports of adverse drug reactions
- Signal detection
- Acceptance of reporting on adverse drug reactions from different sources, its classification and benfit-risk assesment
- Periodical reviews (once a week) of medical databases and high-impact medical journals
- Contact with The Registration Office in all issues related to the safety
- Preparing company for Pharmacovigilance system audits
- Comprehensive handling of Eudravigilance system
- Documentation filling system
- Local company representation in the Pharmacovigilance scope
- QPPV employment opportunies at extremely attractive terms
- Currently we provide adverse drug reaction monitoring in Germany, Netherlands, United Kingdom, Latvia, Bulgaria, Czech Republic, Estonia, Lithuania, Russia, Belarus, Slovakia, Ukraine, Hungary, Azerbaijan. We are planning to expand significantly this offer in the near future
