Pharmacovigilance

Drug Safety Monitoring

• End-to-end ICSRs processing from intake to submission
• Signal detection
• Benefit / Risk balance assessment
• Risk management : RMPs preparation, implementation, effectiveness assessment
• Literature review
• Medical writing : aggregate reports (PSUR, PBRER, PADER, DSUR), ad hoc response to Health & Regulatory Authorities inquiries
• Safety monitoring & medical review in clinical trials

Customized Support to your Drug Safety projects

• Insourced & outsourced temporary staffing of PV professionals
• Drug safety database : implementation, data migration, validation & IT support
• PV quality system & compliance support & oversight
• Internal audit & Health Authority inspection preparation & support
• Local & EU-QPPV representation
• PSMF maintenance
• PV training matrix development
• Regulatory watch
• Medical & scientific information