Drug Safety & Pharmacovigilance
A comprehensive program covering Individual Case Safety Reports (ICSRs), signal detection, risk management plans, and UAE/GCC regulatory submissions — fully aligned with ICH E2E and WHO guidelines.
- ICSR Processing & MedDRA Coding
- Signal Detection & Risk Management
- UAE MOHAP / DHA Submissions
- Argus Safety & Oracle PV Tools
- Aggregate Reporting (PSUR/PBRER)