Foundations of clinical research & PV, regulatory & GCP guidelines, case data extraction, coding & follow-up workflows, Phase IV monitoring, SAE reconciliation, and safety databases — with live Q&A.
Aligned to ICH-GCP, drug safety regulations & real-case practices.
“The session simplified AE case intake and MedDRA coding. I applied these skills in my internship and impressed my supervisor with faster, more accurate entries.”
— Rachel P., Seattle, Washington, USA“Learning SAE reconciliation and PV database workflows gave me confidence to handle case processing independently. I recently secured a role as a Drug Safety Assistant.”
— Ethan L., Ottawa, Ontario, Canada“The real examples on SOP compliance and follow-up communication helped me connect theory to practice. I now feel ready to contribute to a PV team.”
— Meera S., Jaipur, Rajasthan, 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, checklists, and interview-ready takeaways for DSA/PV roles.