Karthika N.

Pharmacovigilance professional with 13+ years of hands-on experience across global pharmacovigilance operations, including ICSR case processing, medical review, quality management, regulatory reporting, vendor oversight, compliance monitoring, and PV system management. Experienced in working across global regulatory requirements and translating complex pharmacovigilance concepts into practical, easy-to-understand learning content.

As a PV professional, I have worked extensively with individual case safety reports (ICSRs), serious and non-serious adverse events, expedited reporting, literature cases, follow-up and amendment cases, case quality review, regulatory submissions, signal management concepts, PSUR/PBRER, RMPs, pharmacovigilance systems, SOPs, CAPA, deviation management, and compliance monitoring.

My experience also includes vendor management, quality oversight, process improvement, training and mentoring of PV teams, providing me with a strong understanding of both the operational and strategic aspects of pharmacovigilance.

As a Pharmacovigilance Tutor, I aim to bridge the gap between theoretical knowledge and real-world industry practices by using practical case scenarios, regulatory examples, workflow-based learning, and industry-relevant discussions. I can support students and aspiring PV professionals in developing a strong foundation in pharmacovigilance and understanding how PV processes are implemented in a real-world pharmaceutical environment.

Key areas I can teach:

* Fundamentals of Pharmacovigilance
* ICSR case processing and workflow
* Seriousness, expectedness and causality assessment
* MedDRA coding concepts
* Case narratives and medical review
* Expedited and regulatory reporting
* Literature surveillance and literature cases
* Follow-up and amendment cases
* Signal detection and management fundamentals
* PSUR/PBRER and RMP fundamentals
* Pharmacovigilance quality management
* SOPs, deviations and CAPA
* Regulatory compliance and inspection readiness
* Vendor management and PV oversight
* Practical case studies and interview preparation
* Career guidance for aspiring PV professionals