Pharmacovigilance & Safety Reporting in Clinical Development

An introduction to pharmacovigilance principles and post‑market/clinical development safety responsibilities. Learners review expedited safety reporting (ICH E2A), Development Safety Update Reports (ICH E2F), and how safety data informs risk‑benefit evaluation across a product lifecycle.

Course Benefits & Career Prospects

• Understand the role of pharmacovigilance in drug development and post‑approval safety.
• Recognize expedited reporting triggers and timelines under ICH E2A.
• Review the structure and purpose of Development Safety Update Reports (DSURs) per ICH E2F.
• Support safety case processing, reporting coordination, or signal tracking under supervision.
• Job placement assistance: PV assistant, safety data coordinator, or combined CTA/PV trainee roles.

Modules

• Introduction to Pharmacovigilance
• Introduction to ICH E2A Guidelines (Expedited Reporting)
• Introduction to ICH E2F Guidelines (Development Safety Update Report – DSUR)