- Preparation of local DDPS (Detailed Description of Pharmacovigilance System) in accordance with PSMF (Pharmacovigilance System Master File)
- Preparation of local PV procedures
- Submission of scientific opinions for harmonization of dynamics of PSUR submission
- Preparation of scientific opinions for determination of type and frequency of RMP submissions
- Advices for submissions of PSURs during MA procedures and renewals of MA
- Preparation of PSUR and RMP statements during MA procedures and renewals of MA
- Preparation of report on performed risk minimization measures during submission of PSURs and RMPs after obtaining of MA
- Preparation, check and review of Dear Doctor Letter (DDL)/Direct Healthcare Professional Communication (DHCP)
- Check, review and submission of educational materials to the competent authorities
