Dear colleagues, X7 Research company offers you to get acquainted with some types of pharmacovigilance services.
- Establishment and maintenance of PV system
- Development of a new PSMF, or peer review of your existing system, maintenance of the PSMF
- Case Management
- Periodic reports (PSUR, DSUR)
- Risk Management (RMP)
- PV database
- Signal Management
- PV Training
- Communication with regulatory agencies
National contact person for pharmacovigilance:
- Single contact point for Authorities 24/7
- PV documentation submission
- Local regulatory knowledge & support
- Reporting of suspected ADRs to local authorities in the local language
- Pharmacovigilance Audit
- PMSF, PSUR, DSUR, RMP development
- SOP development
- Literature screening
- PV Training
And this is not the whole list of services! For more information, please contact us by e-mail email@example.com. Write to us, and X7 Research specialists will find the best solution for your company.
The audit is supervised by the Head of Pharmacovigilance Department at X7 Research, Olga Latysheva.
Olga graduated from the Irkutsk State Medical University, faculty of pharmacy.
- She has been working in the field of pharmacovigilance since 2014, including in such large pharmaceutical companies in St. Petersburg as CJSC Biocad and JSC Vertex.
- Already more than 3 years will perform the functions of an authorized person for Russian pharmaceutical companies. During this time, she was the representative of the companies, which is engaged with the regulatory authorities of Russia, the countries of the EAEU and the CIS.
- Since 2017 she has been working in contract research organization X7 Research.