Aim
Pharmacovigilance for Drug Safety & Efficacy teaches how drug safety is monitored across clinical trials and real-world use. Learn adverse event case processing, coding basics, signal detection concepts, risk management, and safety reporting workflows.
Program Objectives
- PV Basics: drug safety lifecycle, roles, and terminology.
- Safety Data: AE/ADR/SAE, seriousness, severity, expectedness.
- Case Processing: intake, triage, follow-up, QC steps.
- Coding: MedDRA concepts and good coding practice.
- Causality: assessment concepts and clinical context.
- Signal Detection: disproportionality and trend checks (intro).
- Risk Management: risk minimization measures and RMP basics.
- Reporting: narratives, line listings, periodic reports (overview).
- Capstone: build a safety case + mini signal summary.
Program Structure
Module 1: Pharmacovigilance Foundations
- Why PV matters: safety, benefit-risk, compliance.
- PV across phases: trials to post-marketing.
- Key terms: AE, ADR, SAE, SUSAR (intro).
- PV systems: spontaneous reports, registries, literature (overview).
Module 2: Safety Data and Case Intake
- Minimum case criteria and data quality.
- Source types: patients, HCPs, partners, digital.
- Triage: seriousness, expectedness, priority.
- Follow-up questions and documentation.
Module 3: Case Processing Workflow
- Case forms and core fields.
- Narratives: structure and clarity.
- Duplicate detection and reconciliation.
- QC checks and audit readiness.
Module 4: Coding Concepts (MedDRA)
- MedDRA hierarchy and term selection (intro).
- Good coding practice and common errors.
- Product coding concepts and concomitant meds.
- Medical review checkpoints (overview).
Module 5: Causality and Benefit-Risk Thinking
- Causality concepts: temporal association, dechallenge/rechallenge.
- Confounders: disease, interactions, comorbidities.
- Expectedness and labeling concepts.
- Simple benefit-risk framing for safety reviews.
Module 6: Signal Detection and Evaluation
- Signals vs events: definitions and workflow.
- Disproportionality concepts (PRR/ROR overview).
- Trend review: time, geography, batch, population.
- Signal evaluation steps and documentation.
Module 7: Risk Management and Safety Actions
- Risk Management Plan (RMP) structure (overview).
- Risk minimization: education, monitoring, restrictions (intro).
- Safety communications and labeling updates (overview).
- CAPA concepts and safety governance.
Module 8: Safety Reporting and Compliance
- Expedited reporting basics (overview).
- Periodic reports: PSUR/PBRER concepts.
- Line listings and aggregate summaries.
- Inspection readiness and documentation basics.
Final Project
- Process 1–2 sample safety cases (intake → narrative → coding).
- Create a mini signal summary and risk note.
- Submit: case pack + short report.
Participant Eligibility
- Pharmacy, Life Sciences, Biotechnology, Nursing, Medicine students/professionals
- Clinical research associates and PV beginners
- Basic medical terminology helpful
Program Outcomes
- Understand PV terminology and workflows.
- Process safety cases with basic coding and QC.
- Explain signal detection and risk management basics.
- Prepare safety summaries and reports.
Program Deliverables
- e-LMS Access: lessons, sample cases, templates.
- Toolkit: case form, narrative template, QC checklist, signal summary template.
- Assessment: certification after submission.
- e-Certification and e-Marksheet: digital credentials.
Future Career Prospects
- Drug Safety Associate (Entry-level)
- PV Case Processor
- Clinical Safety Trainee
- Regulatory Safety Associate
Job Opportunities
- Pharma/Biotech: drug safety and clinical safety teams.
- CRO/BPO: PV case processing and aggregate reporting units.
- Hospitals: ADR monitoring and pharmacovigilance cells.
- Regulatory/Compliance: safety documentation support roles.
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