The Professional Certificate in Pharmacovigilance program is designed to build a strong foundation in drug safety, risk management, and regulatory reporting. It enables learners to develop the technical expertise needed to work in global pharmaceutical and clinical research environments.
By the end of this course, participants will understand how to identify, assess, and report adverse drug reactions (ADRs), apply international pharmacovigilance guidelines, and use industry-standard tools effectively.
Key Learning Outcomes:
- Master the fundamentals of pharmacovigilance and drug safety
- Learn to identify and assess adverse drug reactions (ADRs)
- Understand regulatory guidelines (ICH, WHO, EMA, USFDA)
- Develop skills in signal detection and risk assessment
- Learn aggregate reporting (PSURs, DSURs)
Who Should Enroll:
- Graduates or postgraduates in Life Sciences, Pharmacy, Medicine, Nursing, or Allied Health fields
- Professionals working in Clinical Research, Drug Safety, or Regulatory Affairs who wish to enhance their skills
- Eligible students or working professionals aspiring to start a career pharmacovigilance domain
Prerequisites:
- Basic understanding of pharmaceutical sciences
- Good command of English language
- Computer literacy for database operations
- Introduction to Pharmacovigilance
- History of Pharmacovigilance
- Pharmaceutical Regulatory Agencies and Organizations
- Brief note on new drug registration process
- Drugs withdrawals
- Pharmacovigilance Methods
- Causality assessment
- Signal detection in Pharmacovigilance
- Guidelines and standards Governing Pharmacovigilance
- Individual Case Safety Reports (ICSRs)
- AE reporting forms
- Medical Dictionary for Drug Regulatory Activities (MedDRA)
- Aggregate safety reports
- Pharmacovigilance Inspections
- UMC Glossaries
Student Reviews
Rahul Menon
September 2, 2025
Very informative and well-structured course. The trainers are experienced and supportive. I got a job in a CRO immediately after completing this course.
Dr. Anjali Patel
July 28, 2025
Excellent course content and practical approach. The case studies and real-world examples made complex concepts easy to understand.
Priya Sharma
August 14, 2025
The sessions were interactive and practical. I gained deep insight into drug safety practices used in the industry. The hands-on training with databases was particularly valuable.