Tier 1 – PV Foundations 

Course Outline:                                   

Module 1 Introduction to PV and Compliance

Module 2 Global Regulatory Frameworks and Systems 

Module 3 Case Intake & ICSR Fundamentals 

Module 4 MedDRA Coding and Standardisation

Module 5 Narrative Writing

Module 6 Quality and Documentation in PV,

Module 7 Signal Detection Basics

Module 8 Career Transition Into Industry 



 

Tier 2 – PV Science and Risk Management  

Course Outline:

Module 1  Orientation & Signal Management Lifecycle

Module 2 Signal Detection Fundamentals

Module 3 Signal Validation & Assessment

Module 4 Literature Screening & Safety Signal Source Management

Module 5 Aggregate Reporting – DSUR Development

Module 6 Aggregate Reporting – PBRER Integration

Module 7 Risk Management Plan (RMP Design)

Module 8 CAPA & Quality System Management

Module 9 Mock Inspection & Regulatory Response

Module 10 Career Readiness & Professional Portfolio

Tier 3 – Advanced PV & Regulatory Strategy

Course Outline:                        

Module 1  Advanced PV Governance & Global Regulatory Frameworks 

Module 2 QPPV Oversight & Compliance Systems 

Module 3 Audit Readiness & Inspection Simulation 

Module 4 Vendor Oversight & Contractual Governance 

Module 5 PV Quality Management & CAPA Leadership 

Module 6 Automation & AI in Pharmacovigilance 

Module 7 Advanced Aggregate Reporting Strategy 

Module 8 Benefit–Risk Communication & Regulatory Engagement 

Module 9 Strategic PV Leadership & Change Management 

Module 10 Capstone Project – Global PV Strategy Simulation. 

Best Value

Full Professional Track

All 3 tiers combined for complete PV career readiness.

£3,499 (Save £1598)