Safety

Pharmacovigilance is dedicated to ensuring the safety of medicines by monitoring and evaluating their risks. Our goal is to detect and prevent adverse effects, ensuring patients receive the maximum therapeutic benefit. Through rigorous monitoring and regulatory compliance, we aim to provide timely, transparent safety data to protect patient well-being.

SOP for Preparation and submission of Periodic Adverse Drug Event Reports (PADERs)

SOP for Collection, Processing and submission of Individual Case Safety Reports (ICSRs)

SOP for Pharmacovigilance Safety Signal Investigation

SOP for SAE Reconciliation

SOP for the Active Pharmacovigilance Plan (Receipt, Handling, Evaluation & Reporting of Adverse Events.)