About the Pharmacovigilance Course
Program Highlights
Course Curriculum
Module 1: Introduction to Pharmacovigilance and Drug Safety
- Define the objectives and global importance of pharmacovigilance
- Analyze the historical evolution and landmark drug safety incidents
- Classify adverse drug reactions (ADRs) and understand their types
- Overview the drug development lifecycle and regulatory checkpoints
Module 2: ADR Reporting Systems and Regulatory Frameworks
- Explain spontaneous reporting systems: WHO-UMC, Vigibase, MedWatch
- Discuss pharmacovigilance guidelines (ICH, EMA, CDSCO, FDA)
- Detect signals and assess risks using various methods
- Apply data mining techniques in safety surveillance
Module 3: Advanced Pharmacovigilance Tools and Technology
- Process cases and write narratives (ICSRs, PSURs)
- Utilize pharmacovigilance software: Argus, ARISg, Veeva Vault Safety
- Integrate AI, machine learning, and automation in drug safety
- Visualize data and create dashboards for safety signal analytics
Module 4: Career Pathways, Compliance, and Future Trends
- Explore roles in PV: Drug safety associate, quality reviewer, risk assessor
- Prepare for audits, inspections, and pharmacovigilance compliance
- Understand global outsourcing and PV operations in India
- Discuss emerging trends: Real-world evidence, mobile reporting apps, and predictive PV models
Tools, Techniques, or Platforms Covered
ARISg
Veeva Vault Safety
Data Visualization Tools
Real-World Applications
- Apply Certificate Course in Pharmacovigilance skills directly to academic research, thesis work, and publications
- Build a professional portfolio showcasing practical Biotechnology competencies
- Solve industry-relevant problems using Certificate Course in Pharmacovigilance methodologies and tools
- Contribute to open-source projects and collaborative research in Biotechnology
- Prepare for competitive examinations, interviews, and professional certifications in Biotechnology
Who Should Attend & Prerequisites
- Industry-recognized e-Certification + e-Marksheet from NanoSchool
- Hands-on training with practical projects and industrial datasets
- Dedicated expert mentorship and doubt resolution
Prerequisites:







