Pharmacovigilance is a system for monitoring, analyzing and evaluating information on the safety of registered medicines. The qualified staff of the TETIS company has been trained and has sufficient experience in pharmacovigilance management.
The range of pharmacovigilance services includes:
- Literature monitoring sources approved in Moldova;
- Local web and social networks pages monitoring;
- Communication betweem MAH and Medicines and Medical Devices Agency if necessary;
- Communication with doctors, patients to gain any information if it necessary for PV issues;
- PV manager availability within 24 hours;
- Ensurance of subcontractor with PV regulations, law, orders addopted în the RM on language stipulated in the contract for pharmacovigilance services;
- Detection, processing, validation and transmittion of signals from subcontractors to Regulatory Affairs and vice versa;
- Trainings on pharmacovigilance to keep the high-level competentce of company personnel involced in functionality of the pharmacovigilance system;
- Prevention of subcontractor about the information that must be submitted to the Agency Medicines and Medical Devices Agency.
- Transmission of SUSARs, PSUR, DSUR, RMP from subcontractor to Agency for Medicines and Medical Devices.