1. Assigning and monitoring interactions of QPPV.
2. Examining local legislation on taxation (including the requirements of the HQs /central office), and verify compliance with the requirements of the current Russian Federation and EAEU laws;
3. Putting together and updating PSMF;
4. Monitoring compliance with the updated requirements of the current legislation
5. Creating and updating SOPs;
6. Mapping, drug information collection;
7. Identifying potential sources of drug safety information;
- Physician, pharmacist, patient, manufacturer and/or MA holder, regulatory authorities;
8. Developing a drug safety reporting form;
9. The minimum amount of information to identify the case, location - corporate website, server;
10. Selecting the site where the information /employee in charge of information processing will be forwarded
11. Identifying appropriate ways for obtaining information
- phone/fax, e-mail, Internet
12. Monitoring literature, official websites in the territories under monitoring
- by INN and trade name, at least once a week
13. Arranging processing, analysis and coding of drug safety information
14. Arranging AEdatabase maintenance;
15. Forwarding safety-related messages to HQs, central office;
16. Determining procedure for developing PSUR and DSUR to be forwarded to the authorized agency;
17. Arranging employee training
18. Developing the risk management systems;
19. Monitoring KPIs for assessing PhV effectiveness;
20. Storage of PhV documentation in line with the local requirements
