This programme in Pharmacovigilance is specifically designed to meet the growing global demand for professionals who can monitor, evaluate, and enhance drug safety. It equips B.Pharm and MBBS graduates with in-depth knowledge of adverse drug reactions (ADRs), regulatory requirements, signal detection, risk management, and global pharmacovigilance practices.

With a curriculum aligned with international standards (ICH, WHO, CDSCO, USFDA, EMA), this program prepares learners for high-demand roles in the pharmaceutical industry, hospitals, regulatory agencies, and contract research organizations (CROs).

Duration:

3–6 months (Full-time / Weekend / Online Mode)

Eligibility:

  • B.Pharmacy, MBBS, BDS, BHMS, BAMS graduates

  • Final-year students may also apply

  • Ideal for working professionals in healthcare or pharmaceutical sectors

Module 1: Introduction to Pharmacovigilance

  • Definition, History, and Objectives

  • Importance in Public Health and Drug Development

  • Evolution of Drug Safety Monitoring Systems

  • Role of Pharmacovigilance in Clinical and Post-Marketing Phases

Module 2: Regulatory Framework & Guidelines

  • WHO Programme for International Drug Monitoring

  • ICH E2E Guidelines on Pharmacovigilance

  • CDSCO Guidelines & PvPI (Pharmacovigilance Programme of India)

  • USFDA, EMA, MHRA, and other global regulatory agencies

Module 3: Adverse Event Reporting

  • Types of Adverse Events (ADR, SAE, SUSAR)

  • Reporting Timelines and Formats (CIOMS, MedWatch)

  • Sources of Safety Data (Spontaneous Reports, Literature, Studies)

  • Spontaneous vs. Solicited Reporting

Module 4: Signal Detection and Risk Management

  • What is Signal Detection?

  • Risk Evaluation and Mitigation Strategies (REMS)

  • Benefit-Risk Assessment

  • Risk Minimization Measures and Communication

Module 5: Pharmacovigilance Processes and Systems

  • Case Processing Lifecycle

  • Case Narrative Writing

  • Medical Coding (MedDRA, WHO-DD)

  • Use of PV Databases: Argus, ARISg, VigiBase

Module 6: Clinical Trial Safety & Post-Marketing Surveillance

  • Safety Monitoring in Clinical Trials

  • Roles of DSUR, PSUR, PADER, and PBRER

  • Pharmacovigilance in Special Populations

  • Post-Marketing Commitments

Module 7: Quality Management in PV

  • Audits and Inspections in Pharmacovigilance

  • CAPA and Compliance

  • SOPs, Documentation & Record Maintenance

  • Quality Metrics in PV Systems

Module 8: Career Essentials

  • Resume Building for PV Roles

  • Interview Questions and Industry Case Studies

  • Overview of PV Job Roles (Case Processor, Safety Reviewer, PV Scientist)

  • Key Skills: Attention to Detail, Medical Writing, Data Entry, Terminology

Project / Case Study

  • Real-World AE Case Handling Simulation

  • Signal Detection Exercise using Literature Reports

  • Narrative Writing Practice

  • MedDRA Coding Exercise

Assessment

  • Module-wise Online Quizzes

  • Final Project/Assignment Evaluation

  • Certificate of Completion with Grades

Key Learning Outcomes

Upon successful completion, learners will:

  • Understand global pharmacovigilance regulations and systems

  • Process and evaluate ADR and safety reports

  • Use medical dictionaries and reporting tools

  • Apply signal detection and risk management practices

  • Be industry-ready for roles in drug safety and compliance

Career Opportunities

  • Drug Safety Associate / Case Processor

  • Pharmacovigilance Officer / Executive

  • Safety Data Analyst

  • Signal Detection Specialist

  • Regulatory Affairs – Safety Submissions

  • Medical Reviewer / Scientific Writer

Related courses

Clinical Research