Certificate in PHARMACOVIGILANCE
Program Overview
Duration: 3 months
This certificate course typically covers the principles and practices of monitoring and assessing the safety of pharmaceutical products. It includes topics such as adverse drug reaction reporting, drug safety regulations, risk management, and pharmacovigilance methodologies. The course may also delve into drug surveillance systems, signal detection, and pharmacovigilance in clinical trials and post-marketing surveillance. Participants often gain practical skills through case studies and real-world examples, preparing them for roles in pharmaceutical companies, regulatory agencies, and research organizations involved in drug safety.
Career Benefits in Pharmacovigilance
Graduates of the Certificate Program in Pharmacovigilance gain access to a wide range of career opportunities in pharmaceutical companies, regulatory agencies, clinical research organizations (CROs), and healthcare institutions. Potential roles include Pharmacovigilance Associate, Drug Safety Specialist, Pharmacovigilance Officer, and Pharmacovigilance Manager. With the increasing emphasis on drug safety and regulatory compliance globally, pharmacovigilance professionals are in high demand, offering excellent career growth prospects and job security.
Potential Employment Opportunities
In India, graduates of the Certificate Program in Pharmacovigilance can explore opportunities in pharmaceutical companies such as Sun Pharmaceutical Industries, Cipla, Dr. Reddy’s Laboratories, as well as multinational corporations with a presence in India. Additionally, regulatory bodies such as the Central Drugs Standard Control Organization (CDSCO) and the Pharmacovigilance Programme of India (PvPI) offer employment opportunities in drug safety monitoring and regulatory compliance. Internationally, pharmacovigilance professionals are in demand in countries with well-established pharmaceutical industries such as the United States, United Kingdom, Canada, and European Union member states.
CONTENT HIGHLIGHTS
MODULE 1
Introduction to Pharmacovigilance
- Pharmacovigilance (WHO Definition )
- History of Pharmacovigilance
- Scope and Purposes of Pharmacovigilance
- Basic Concepts in Pharmacovigilance
- Types of Pharmacovigilance
- Career Opportunities in Pharmacovigilance
MODULE 2
Introduction to Drug Discovery and Development
- Discovery and Development
- Introduction to clinical Research
- Drug Review
- Post Market Drug Safety Monitoring
MODULE 3
Drug Dictionaries , ADR Dictionaries and Coding of the event
- WHO Drug Dictionary
- COSTART
- MEDRAA
- ADR Classification
MODULE 4
Introduction to Casualty Assessment
- WHO- UMC Casualty Assessment System
- Seriousness & Expectedness & Causality Assessment Criteria
- Why Casualty Done
MODULE 5
Regulatory Aspects of Pharmacovigilance
- WHO-UMC (Uppsala Monitoring Committee
- CIOMS
- ICH-GCP
- European Pharmacovigilance System
- Different Regulatory Authority
MODULE 6
Pharmacovigilance Data Management
- Pharmacovigilance data management and case Processing
- Risk Management Plan in Pharmacovigilance
- WHO Pharmacovigilance Programme
- Pharmacovigilance Programme in India
- Good Pharmacovigilance Practices
Additional Details:
Participants will have access to industry-standard pharmacovigilance software and databases to gain practical experience in adverse event reporting, signal detection, and data analysis. Upon successful completion of the program, participants will receive a Certificate in Pharmacovigilance from Bezel Institute of Healthcare Studies, enhancing their credentials and marketability in the pharmaceutical and healthcare industries.
