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)
- Gain hands-on experience with pharmacovigilance databases
- 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
- Students aspiring to start a career in the Pharmaceutical or CRO industry
- Quality Assurance professionals in pharmaceutical companies
- Medical writers and regulatory affairs professionals
Prerequisites:
- Basic understanding of pharmaceutical sciences
- Good command of English language
- Computer literacy for database operations
Module 1: Introduction to Pharmacovigilance
- History and evolution of pharmacovigilance
- Basic concepts and terminology
- Role of pharmacovigilance in drug development
- Global pharmacovigilance landscape
Module 2: Drug Development and Safety Regulations
- Drug development lifecycle
- Pre-clinical and clinical safety assessment
- Post-marketing surveillance
- Regulatory framework and guidelines
Module 3: Adverse Event Reporting & Case Processing
- Types of adverse events
- Case processing workflow
- Data quality and validation
- Timeline requirements for reporting
Module 4: Signal Detection and Risk Assessment
- Signal detection methodologies
- Risk-benefit assessment
- Risk management plans
- Risk communication strategies
Module 5: Regulatory Guidelines
- ICH guidelines (E2A, E2B, E2C, E2D)
- WHO guidelines
- EMA and USFDA requirements
- Regional variations and compliance
Module 6: Aggregate Reporting
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs)
- Risk Evaluation and Mitigation Strategies (REMS)
- Benefit-Risk Assessment Reports
Module 7: Pharmacovigilance Database Tools
- Introduction to safety databases
- Data entry and case processing
- Query building and reporting
- Data analysis and visualization
Module 8: Career Development in Drug Safety
- Career opportunities in pharmacovigilance
- Industry networking and professional development
- Certification and continuing education
- Interview preparation and resume building
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.