With over 20 years of combined experience as a physician, research assistant and drug safety professional, I have specialized
in the processing, medical writing, and review of individual case reports and aggregate reports for both clinical and post-
marketing products and authoring research publications.
Experience working in multiple therapeutic areas including Immuno-Oncology, Cardiology, Hematology-oncology,
Nephrology, Neuroscience, Infectious diseases, and others.
Skilled at evaluating the medical records from clinical trials and post marketing setting for medicinal products in compliance
with current regulatory regulations and timelines.
Analyzed and wrote detailed case summaries, commented on the causal relationship between the investigational medications
and adverse events, and evaluated the risk-benefit of study therapies to regulatory authorities including Food and Drug
Administration (FDA), European Medicines Agency (EMA), and others.
Performed peer review of the narratives and case summaries authored by colleagues and oversight of similar activities
performed by CROs (contract research organizations).