Pharmacovigilance

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 CONSULTING, in accordance with Good Pharmacovigilance Practices (GVP) and other legislation Pharmacovigilance System in accordance with the legislation in force:

 

Pharmacovigilance System

• Services of Qualified Person for Pharmacovigilance (EU-QPPV);
• Local contact person for pharmacovigilance
• 24/7 availability
• Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
• Elaboration and review of work procedures/SOPs
• ICSR (Individual Case Safety Report) management - reception, treatment, medical evaluation, electronic transmission to authorities and/or partners
• Possibility of using a validated safety database software for managing ICSRs
• Periodic monitoring of national and international literature
• Regulatory Intelligence
• Management of Eudravigilance/Art.57/XEVMPD
• Signal management (including EVDAS)
• Preparation of of Periodic Safety Reports (PSUR)
• Preparation of Risk Management Plan (RMP)
• Educational materials and communication with healthcare professionals
• Follow-up of safety and efficacy post-authorization studies (PASS and PAES)
• Preparation and review of Pharmacovigilance agreements (SDEAs - Safety Data Exchange Agreements)
• Pharmacovigilance training
• Pharmacovigilance audits
• Support in Pharmacovigilance inspections
• Review of the Quality System in Pharmacovigilance

 

Other services

• Management of medical information requests
• Management of technical complaints