Deep medical case reviews, advanced narrative writing, AE causality assessments, aggregate reporting, signal evaluation, regulatory submission expectations, and data integrity checks — with live Q&A.
Aligned to global medical reviewer expectations & regulatory compliance.
“The focus on medical narratives and causality assessment gave me the expertise to handle complex ICSR reviews confidently. I was promoted to a Medical Reviewer role within my PV team.”
— Sophia L., Houston, Texas, USA“Learning aggregate reporting and reviewer checklists helped me understand how DSURs and PBRERs are built. I feel much more confident supporting my company’s global submissions.”
— Ethan M., Ottawa, Ontario, Canada“The practical exercises on safety signal evaluation and data integrity prepared me for real audit scenarios. I am now ready to apply for senior medical review positions.”
— Deepa M., Bangalore, IndiaClinical Operations & Pharmacovigilance Expert
Dr. Nate has 25+ years in clinical research and drug safety, with extensive reviewer experience in medical narratives, causality, and aggregate reporting. Expect rigorous, inspection-ready practices aligned to ICH-GCP, GVP, and global submission standards.