Pharmacovigilance

At Convex, we are committed to safeguarding patient safety and supporting our partners with end-to-end pharmacovigilance (PV) solutions. With over three decades of experience in clinical research and regulatory operations, we now extend our expertise to provide comprehensive drug safety services.

Our pharmacovigilance team specializes in monitoring, assessing, and reporting adverse events (AEs) and serious adverse events (SAEs) in accordance with global regulatory standards (FDA, EMA, ICH, GVP).

Safety Monitoring & Reporting

• SAE/overdose/pregnancy reporting
• Safety Database management
• CIOMS-I forms generation
• Signal detection activities
• SUSAR reporting in EU
• Periodic reporting