Program Overview
Clinovalife offers Pharmacovigilance (PV) course that provides a comprehensive understanding of drug safety monitoring throughout the lifecycle of pharmaceutical products. The course focuses on adverse event collection, safety data processing, case assessment, regulatory reporting, and risk management activities required by global regulatory authorities such as the FDA, EMA, and ICH.
Program Highlights
- End-to-End Pharmacovigilance Workflow
- Adverse Event Case Processing Training
- Global Regulatory Reporting Requirements
- Safety Databases and Signal Detection Concepts
- Risk Management and Benefit–Risk Evaluation
- Industry Case Studies and Practical Exercises
Course Curriculum
Module 1: Introduction to Pharmacovigilance
Module 2: Drug Development & Safety Monitoring
Module 3: Adverse Events & Serious Adverse Events
Module 4: Case Processing Workflow
Module 5: Safety Databases
Module 6: Medical Coding
Module 7: Global Regulatory Reporting
Module 8: Periodic Safety Reports
Module 9: Signal Detection & Risk Management
Module 10: Pharmacovigilance Quality Systems
Module 11: Pharmacovigilance in Post-Marketing
Module 12: Career Opportunities in Pharmacovigilance
Learning Outcomes
- Understand pharmacovigilance processes and regulatory requirements
- Identify and classify adverse events and serious adverse events
- Understand case processing and safety reporting workflows
- Apply medical coding standards such as MedDRA
- Understand signal detection and risk management concepts
Target Audience
- Life Science and Pharmacy Graduates
- Clinical Research Professionals
- Healthcare and Pharmaceutical Professionals
- Students interested in Drug Safety careers
Program Duration
Total Duration: 3 Months
Includes Practical Case Studies and Exercises
Tools Used
- Pharmacovigilance Safety Databases (concept overview)
- MedDRA Coding Dictionary
- WHO Drug Dictionary
- Microsoft Excel
- Sample Safety Case Reports
Certification
Participants who successfully complete the training program and final assessment will receive a Certificate in Pharmacovigilance.
Contact / Admissions
Email: Info@clinovalife.com
Phone: +91 XXXXXXXX
Website: www clinovalife.com
Phone: +91 XXXXXXXX
Website: www clinovalife.com