Follow us

HomePharmacy Test Series

Pharmacy Test Series

Pharma Covigilance Test Series

Pharmacovigilance MCQ test series for PV certification. ICH E2 guidelines, ADR reporting, signal detection, CIOMS, EudraVigilance, AURA AI analytics.

Price

· Duration : 60 Days


🤖 AI Tutor
♾️ AI Support
📱 AI Analytics

Introduction

About the Pharmacovigilance Certification Examination — Test Series

?? Pharmacovigilance
? MCQ Test Series
?? ICH E2 · WHO · EMA
?? AURA AI Tutor

The Pharmacovigilance Certification Test Series is TerraLeap's dedicated MCQ preparation platform for pharmaceutical and healthcare professionals preparing for pharmacovigilance (PV) certification examinations — including ISPOR, DIA, and institutional PV certifications — and for professionals building ICH E2 competency for drug safety roles in pharmaceutical companies and regulatory agencies.

Pharmacovigilance certification examinations assess competency across the complete PV framework: ICH E2A/E2B/E2C/E2D/E2E/E2F guidelines, adverse drug reaction (ADR) classification and reporting, signal detection and evaluation, PSUR/PBRER preparation, risk management plans (RMP), global regulatory submission requirements (EudraVigilance, VigiBase/WHO, FDA MedWatch, CDSCO PvPI), and PV audits. These competencies are assessed through MCQ-based professional examinations and internal pharmaceutical company PV qualification programmes.

Powered by AURA AI, the platform delivers personalised coaching, domain-wise analytics, and spaced repetition calibrated to ICH E2 series guidelines, EMA GVP Modules, FDA safety reporting regulations, and WHO pharmacovigilance standards.

ICH E2

Complete Series

EudraVigilance

EU Reporting

Signal

Detection

AURA

AI Tutor Included

?? ICH E2 series — the global PV standard. Every question is anchored in ICH E2A/B/C/D/E/F guidelines, EMA GVP Modules I–XVI, FDA 21 CFR Parts 310/314, and WHO pharmacovigilance standards — covering the complete global PV regulatory landscape.

PV certified. Drug safety expert. Pharmaceutical career advanced.

Pharmacovigilance Test Series — ICH E2 series, signal detection, EudraVigilance, AURA AI coaching.

Programme Scope

What this test series covers

The Pharmacovigilance Test Series covers the complete PV regulatory framework — from ADR classification and ICH E2 reporting timelines to signal detection, PSUR/PBRER preparation, and global regulatory submissions across FDA, EMA, and WHO databases.

??

ICH E2 Guidelines & ADR Reporting (~25%)

ICH E2A (expedited reporting), E2B(R3) (electronic transmission), E2C/E2D (PSURs/PSADAs), E2E (pharmacovigilance planning), E2F (development safety) — the complete ICH E2 PV series.

??

Signal Detection & Evaluation (~20%)

Quantitative signal detection (PRR, ROR, BCPNN), Qualitative signal evaluation, Signal management process, EMA signal detection methodology, VigiBase analysis.

??

PSUR/PBRER & Risk Management Plans (~20%)

Periodic Safety Update Report preparation, PBRER structure (ICH E2C R2), Risk Management Plan (EU RMP), Risk Evaluation and Mitigation Strategies (REMS — FDA).

??

Global Regulatory Submissions & Databases (~15%)

EudraVigilance (EU), FDA MedWatch/FAERS, WHO VigiBase/UMC, CDSCO PvPI (India), PMDA (Japan) — global PV reporting systems.

??

EMA GVP Modules & FDA Regulations (~15%)

GVP Modules I–XVI, FDA 21 CFR Parts 310/314/600, IND safety reporting, NDA/BLA post-marketing safety requirements, PV audits and inspections.

???

PV in Clinical Trials & Special Populations (~5%)

SUSAR/SUSUR reporting, Clinical trial safety reporting timelines, PV in paediatric/geriatric/pregnancy populations, Risk-benefit assessment.

ICH E2 · EMA GVP · FDA safety regulations. Global PV expertise.

Every PV certification domain covered with ICH E2-anchored MCQs and real-time performance analytics.

Learning Objectives

What this test series achieves

To equip pharmaceutical and healthcare professionals with the ICH E2 regulatory knowledge, signal detection competency, and global PV reporting expertise required to pass pharmacovigilance certification examinations and excel in drug safety roles.

01

To assess PV certification readiness across all pharmacovigilance competency domains through timed MCQ mock examinations

02

To master ICH E2 series MCQs — E2A expedited reporting timelines, E2B(R3) electronic format, E2C/PBRER structure, and E2F development safety updates

03

To develop signal detection competency — quantitative methods (PRR, ROR, BCPNN), EMA signal management process, and VigiBase signal evaluation

04

To build PSUR/PBRER and RMP preparation knowledge — PBRER ICH E2C(R2) structure, EU RMP requirements, and FDA REMS elements

05

To master global regulatory database MCQs — EudraVigilance, FDA FAERS, WHO VigiBase, CDSCO PvPI — reporting requirements and submission timelines

06

To identify domain performance gaps using AURA analytics calibrated to ICH E2 and EMA GVP PV competency frameworks

07

To track readiness with a real-time PV certification Pass Probability Score updated after every session

08

To reinforce EMA GVP Module MCQs — Modules I–XVI covering the complete EU pharmacovigilance system for medicinal products

Eight objectives. PV certified. Drug safety expert. Global pharma career.

The Pharmacovigilance Test Series delivers each objective through AI-powered ICH E2-anchored practice and AURA analytics.

Target Audience

Who can enrol

The Pharmacovigilance Test Series is designed for pharmaceutical and healthcare professionals seeking pharmacovigilance certification or building PV competency for drug safety roles.

Whether you are a pharmacist, physician, nurse, or life sciences graduate working in or transitioning to pharmacovigilance, drug safety, or regulatory affairs — this test series builds the ICH E2 regulatory knowledge and signal detection competency assessed in PV certification examinations.

Designed for these candidates

??

01

Drug safety associates, PV specialists, and pharmacovigilance coordinators preparing for institutional or professional PV certification examinations

??

02

Regulatory affairs and clinical research professionals transitioning to pharmacovigilance roles who need ICH E2 and GVP module competency

??

03

PV certification re-attempt candidates who need data-driven ICH E2 domain gap analysis for a successful re-sit

??

04

Professionals who want AURA AI analytics and real-time PV certification readiness scoring across all ICH E2 and GVP competency domains

PV certified. Drug safety expert. Global pharmaceutical career.

Enrol in the Pharmacovigilance Test Series and build the ICH E2 mastery, signal detection competency, and AURA AI confidence to certify.

Programme Certification

Your certificate

Upon successful completion of this programme, you will receive a digital certificate recognising your achievement and the competencies you have acquired throughout the course.

Certificates for TerraLeap programmes are issued and signed by authorised TerraLeap representatives. For programmes delivered in collaboration with universities, institutions, or industry organisations, certificates are jointly issued and co-signed by authorised representatives of both TerraLeap and the respective partner.

Each certificate carries a unique Certificate ID and QR code to enable instant authenticity verification — making it easy to share with employers, licensing bodies, or professional networks as evidence of your learning.

Note on scope. TerraLeap certificates confirm successful completion of the respective programme and recognise your professional development and continuing education. They do not constitute a professional licence or regulatory authorisation unless explicitly stated in the programme description.

TERRALEAP
T
Certificate ID
TL-2026-AB7K3X9P
Official
Seal
Certificate of Completion

Successfully Completed

Awarded in recognition of academic achievement

This is to certify that

XXXXX

has successfully completed the prescribed course of study, demonstrating commitment, diligence, and proficiency in Pharma Covigilance Test Series and is hereby awarded this certificate by TerraLeap, recognising the candidate's mastery of the syllabus and successful evaluation.

Grade
A+
Completion Date
01 Sep 2026
Issued On
01 Sep 2026

Hi! 👋 Need help choosing?
I can help you find the right licensing exam in under a minute.