Pharmacovigilance Specialist (Drug Safety)

Build job-ready pharmacovigilance skills to protect patients, keep products compliant, and support market access. Learn to apply EU GVP, manage FDA post market safety via FAERS, and design effective Risk Management Plans using ICH/EMA guidance. Gain confidence in compliant case handling, aggregate reporting, signal evaluation, and inspection readiness for roles across sponsors, CROs, and vendors.

Estimated path length

34 hours

Note:

100% online, self-paced

Introduction to Pharmacovigilance

Explore the essentials of Pharmacovigilance in the pharma sector, focusing on safety, compliance, and historical impacts in our in-depth course.

Pharmacovigilance System

Learn about the Pharmacovigilance System, including identifying safety information, understanding safety databases, and key PV processes and roles to ensure drug safety.

Advanced Case Processing and Safety Database Management

Master advanced pharmacovigilance with this online course: manage complex ICSRs, MedDRA coding, narratives, reconciliation, and CAPA. Build inspection-ready skills for regulatory compliance and patient safety.

Aggregate Report Writing in Pharmacovigilance

An advanced course on creating inspection-ready aggregate reports (PSUR, PBRER, DSUR) that meet EMA, FDA, and PMDA requirements through robust planning, quality control, and regulatory response strategies.

Risk Management Planning in Pharmacovigilance

Master advanced Risk Management Planning in Pharmacovigilance to design, implement, and evaluate inspection-ready RMPs that meet EMA, ICH, and global regulatory requirements.

Pharmuni Certificate

Developed by Zamann Pharma Support, a TÜV ISO 9001-certified quality management service provider for European pharmaceutical companies,