Pharmacovigilance

The pharmaceutical department is responsible for activities related to the detection, evaluation, knowledge and prevention of adverse reactions associated with human and veterinary use medicines, guaranteeing continuous and effective monitoring of their safety.

ZEMIR PHARMA CONSULTING, following Good Pharmacovigilance Practices (GVP) and other legislation in force, offers an ‘end-to-end’ service or specific support in each area according to the holder's needs.

 

Pharmacovigilance System

• Qualified Person for Pharmacovigilance services (EU-QPPV)
• Local contact person for pharmacovigilance matters (Local QPPV)
• 24/7 availability
• Pharmacovigilance System Master File (PSMF) preparation and maintenance
• Drafting and reviewing work procedures/SOPs
• Individual Case Safety Reports (ICSRs ) management - receipt, processing, medical assessment, electronic transmission to authorities and/or partners
• Validated safety database software to manage ICSRs
• Local and worldwide literature review
• Regulatory Intelligence
• Eudravigilance/Art.57/XEVMPD management
• Signal management, including EVDAS
• Periodic Safety Reports (PSUR/PSUSA) elaboration and submission
• Risk Management Plans (RMP) elaboration and submission
• Educational materials and direct healthcare professional communications
• Post-authorisation safety and efficacy studies (PASS and PAES) support
• Pharmacovigilance agreements (SDEAs) management
• Pharmacovigilance training
• Pharmacovigilance audits
• Pharmacovigilance inspections support
• Pharmacovigilance quality system review

 

Other services

• Medical information requests management
• Quality complaints management