Deep-dive MedDRA & causality, RMP/REMS, Argus Safety (basic→advanced), PQC & CAPA, aggregate reporting (PSUR/PBRER/PADER/DSUR), signal detection and practical case scenarios — plus live Q&A.
Aligned to global safety standards, real-case software demos, advanced PV topics.
“The session on MedDRA coding and causality assessments gave me the clarity I needed to process ICSRs with confidence. I recently secured an advanced PV role in my company.”
— Olivia P., Raleigh, North Carolina, USA“Learning about Argus Safety workflows and aggregate reports (PSURs, DSURs) made me much more effective in my daily case processing tasks. It helped me step up to a senior drug safety position.”
— Liam T., Montreal, Quebec, Canada“The practical case scenarios on PQC, CAPA, and REMS prepared me to handle real audit situations. I feel confident moving into advanced pharmacovigilance roles.”
— Aisha K., Pune, IndiaClinical Operations & Pharmacovigilance Expert
Dr. Nate has 25+ years in clinical research and drug safety. He has led teams using CTMS/eTMF and safety systems such as Oracle Argus and Veeva, applying RBM principles with strong regulatory rigor (ICH-GCP, GVP, HIPAA). Expect practical workflows, advanced checklists, and interview-ready takeaways for ADSA roles.