Diploma in Pharmacovigilance - MedDRA, Causality & Reporting

“This course contains the use of artificial intelligence.”

Master global PV standards with practical skills in ICH‑GCP, MedDRA coding, causality assessment, and modern signal detection for real‑world pharmaceutical compliance

Step into the world of modern pharmacovigilance and gain the skills that global pharmaceutical companies expect from top PV professionals.

This diploma‑level program is designed to take you from foundational understanding to confident, industry‑ready competence in safety reporting, regulatory compliance, and real‑world case assessment.

Across the course, you’ll learn how to apply ICH‑GCP principles, perform accurate MedDRA coding, conduct structured causality assessments, and interpret signal detection outputs with clarity and confidence. Every module is built to mirror the expectations of regulatory authorities and the workflows used in leading CROs, biotech firms, and pharmacovigilance departments.

You’ll explore:

• How global safety regulations shape PV reporting standards

• The practical steps behind high‑quality case processing

• MedDRA hierarchy, coding strategy, and common coding pitfalls

• Causality assessment frameworks used by industry experts

• How signals are identified, validated, and escalated

• The mindset and analytical approach required for compliant documentation

Whether you’re entering the field, strengthening your professional profile, or preparing for a PV‑related role, this course gives you the structure, clarity, and applied knowledge needed to stand out.

By the end, you’ll be able to confidently contribute to pharmacovigilance operations, understand regulatory expectations, and perform core PV tasks with accuracy and professional discipline.