Oluni Odunlami, MD

Physician | Drug Safety | Medical Reviewer

A well trained Physician with experience in Drug Safety and Clinical Research experience and years of monitoring safety in clinical trials and the medical device/drug development industry. Signal detection skills in quantitative and qualitative research methods. Lead case processing medical review activities providing proper AE/SAE triage, seriousness, causality and expectedness assessment of expedited reports to regulatory agencies. Medical and technical documentation skills in authoring aggregate periodic safety reports including DSUR, PSUR/PBRER, and FDA PADERs. Excellent presentation skills to communicate safety and risk management activities for safety of subjects in clinical trials and post-marketing. Vast capability to monitor multiple research protocols in various study phases and different therapeutic areas.