Pharmaceutical department is responsible for activities related to the detection, evaluation, knowledge and prevention of adverse reactions associated with medicines ensuring continuous and effective monitoring of their safety.
ZEMIR PHARMA Pharmacovigilance System in accordance with the legislation in force:
Appointment of Qualified Person for Pharmacovigilance (QPPV);
Appointment of the contact person for pharmacovigilance matters 24h
Tracking of Periodic Safety Reports / Calendar management of PSURs submissions;
Weekly search for Adverse Drug Reactions (ADRs) in the international literature. Report sent to client.
Weekly search forAdverse Drug Reactions (ADRs) in the national literature. Report sent to client.
Pharmacovigilance training for your company employees (face-to-face: 2h / year);
Pharmacovigilance training for new employees in your company 1 hour in person, after which they will be integrated into the annual plan
Supply and implementation / adaptation of SOP's of the new legislation on pharmacovigilance
Management of ICSR (Individual Case Safety Reports) - treatment, causality analysis and transmission of expeditious reports of adverse drug reactions through EUDRAVIGILANCE
Pharmacovigilance procedures analyzed by a physician(s).
Elaboration of Risk Management Plans
Development of Pharmacovigilance System Master File.
Signal detection in pharmacovigilance, including EVDAS review.
Signal validation procedures.
Support for post-authorization safety and efficacy studies (PASS and PAES)
Risk management systems
Pharmacovigilance quality systems
Monitoring of risk minimization measures