Role-based projects in pharmacovigilance: medical record extraction, CIOMS line listing, SOP quality, SAE reconciliation, PSUR submissions, signal detection, labeling edit checks, and SUSAR handling — plus live Q&A.
Aligned to job-task projects; case studies & role-based exercises included.
“The live project on CIOMS line listings and SUSAR reporting gave me hands-on experience I could showcase in my interviews. I recently transitioned into a Drug Safety Coordinator role.”
— Natalie S., Philadelphia, Pennsylvania, USA“Working through SAE reconciliation and PSUR preparation exercises helped me understand how safety and clinical data connect. It boosted my confidence to take on PV project work.”
— Daniel K., Edmonton, Alberta, Canada“The role-based tasks on case narratives and query resolution mirrored real-world PV work. I now feel well-prepared to handle day-to-day responsibilities in a CRO setting.”
— Rohit M., Chennai, IndiaClinical Operations & Pharmacovigilance Expert
Dr. Nate has 25+ years in clinical research and drug safety, leading teams across CTMS/eTMF and safety systems (e.g., Oracle Argus, Veeva). Expect practical, project-ready workflows aligned to ICH-GCP, GVP, HIPAA.