Erugo Oriji

• Perform case processing activities for adverse events from receipt to case closure in accordance with ICH-GCP and FDA/EMA guidelines. • Experienced in seriousness, causality and expectedness assessment. • Processed serious adverse event (SAE) and non-serious adverse event reports, from post marketing and clinical trials. • Effectively maintain the safety data base and corresponding entry guidelines with assurance of quality of data. • Efficient in identifying and tracking the serious adverse events and non-serious adverse events. • Proficient in consistent coding of diseases, adverse events, and medication according to the Project-specific coding conventions. • Experienced with WHODD and MedDRA coding. • Drafted individual case summary reports and wrote concise case specific narratives. • Interaction on a regular basis with contract clinical research organizations to resolve safety-related issues. • Attended internal meetings and summarized weekly safety metrics for assigned products. • Prepared clinical narrative summaries for AE reports from clinical studies and spontaneous post-marketing reports. • Accurately entered data from source documents/ call center reports/ medical report,eTMFs, and proofread for completeness, accuracy and consistency of information. • Received and tracked information regarding potential adverse events submitted by all reporters including consumers, healthcare professionals, co-manufacturers, call centers, medical information centers, quality assurance and other company representatives accurately within defined reporting timelines.