Conducted weekly local literature screening and performed Regulatory Intelligence tasks, ensuring proactive identification and management of drug safety signals.
Authored and submitted critical pharmacovigilance documents, including Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and Pharmacovigilance System Master Files (PSMFs), maintaining high accuracy.
Processed and coded Adverse Events (AEs) and product information, writing comprehensive narratives and managing literature activities in Arabic, English, and French to meet internal and project timelines.
Ensured strict adherence to quality, productivity, and delivery standards, maintaining full compliance with project processes and activities for all pharmacovigilance operations.
Identified and reported quality issues to senior management, demonstrating strong problem-solving skills and contributing to continuous process improvement.