Safety Operations

Managing day-to-day pharmacovigilance (PV) activities requires precision, consistency, and full compliance with global regulations. At MedWatch Consulting, we provide comprehensive safety operations services that cover the complete spectrum of case processing, risk management, and reporting.

Our team ensures accurate and timely Individual Case Safety Report (ICSR) processing and submissions, supports continuous signal detection and literature monitoring, and manages the preparation of aggregate safety reports such as DSURs and PSURs. Each activity is performed in alignment with FDA, EMA, and ICH requirements to maintain both compliance and patient safety.

With our proven expertise, we help organizations streamline safety operations, reduce risks, and build confidence that their PV systems are inspection-ready and future-proof.