Question 1

What is pharmacovigilance?

Accepted Answer

Pharmacovigilance (PV) is the science and set of activities concerned with detecting, assessing, understanding and preventing adverse effects or any other drug-related problems. Its goal is to monitor the safety of medicines throughout their lifecycle and protect patients.

Question 2

What is an ICSR in pharmacovigilance?

Accepted Answer

An ICSR (Individual Case Safety Report) is a structured report describing a single adverse event experienced by a patient in association with a medicinal product. ICSRs are the core unit of safety data that companies collect, assess and submit to regulators.

Question 3

What is ICSR case processing?

Accepted Answer

ICSR case processing is the end-to-end handling of an individual case — from intake and data entry, through medical coding (e.g. MedDRA), causality and seriousness assessment, medical review and quality checks, to regulatory submission. Each safety-critical step is reviewed by qualified professionals.

Question 4

What is the difference between E2B(R3) and E2B(R2)?

Accepted Answer

E2B(R2) and E2B(R3) are ICH standards for electronically exchanging ICSRs. E2B(R3) is the newer XML-based format required by major regulators such as the EMA; it supports richer data, better structure and clearer traceability than the older E2B(R2) format.

Question 5

What is a PSMF (Pharmacovigilance System Master File)?

Accepted Answer

A PSMF is a document that describes the pharmacovigilance system a Marketing Authorisation Holder uses for its medicinal products. It covers the QPPV, organisational structure, procedures, safety database, quality system and more, and must be kept current and available for inspection.

Question 6

What is signal detection in pharmacovigilance?

Accepted Answer

Signal detection is the process of reviewing safety data to identify new or changing information about a possible causal relationship between a medicine and an adverse event. Detected signals are then evaluated, and any confirmed safety concern is documented and acted upon.

Question 7

What are aggregate reports (PSUR, PBRER, DSUR)?

Accepted Answer

Aggregate safety reports summarise the safety profile of a product over a defined period. Common types include the PSUR/PBRER (periodic benefit-risk evaluation for marketed products) and the DSUR (development safety update report for products in clinical development).

Question 8

What is a QPPV?

Accepted Answer

A QPPV (Qualified Person for Pharmacovigilance) is the individual responsible for establishing and maintaining a company's pharmacovigilance system in the EU. The QPPV oversees the safety profile of the products and acts as a single point of contact for regulators, supported by defined backup arrangements.

Question 9

What is literature monitoring in pharmacovigilance?

Accepted Answer

Literature monitoring is the ongoing, systematic review of scientific and medical publications to identify adverse events, safety information and potential ICSRs relating to a company's products. It is a regulatory expectation and a key input to safety surveillance.

Question 10

What is 21 CFR Part 11?

Accepted Answer

21 CFR Part 11 is a US FDA regulation that sets requirements for electronic records and electronic signatures — including access controls, audit trails and validation — so that electronic systems used in regulated activities are trustworthy, reliable and traceable.

Question 11

What makes HAROM India different from other PV providers?

Accepted Answer

HAROM brings together regulatory strength, AI-assisted automation and expert delivery. Our software and services are built for GVP and 21 CFR Part 11, and every safety-critical decision is reviewed by qualified professionals.

Question 12

Do you offer both software and services?

Accepted Answer

Yes. You can license the HAROM Safety Vault platform and products, use our expert PV services, or combine both — one partner for your whole pharmacovigilance programme.

Question 13

Which industries and organisations do you support?

Accepted Answer

We work with pharmaceutical companies, MAHs, biotech firms and CROs of every size — from single-product companies to global portfolios.

Question 14

Do you only serve clients in India?

Accepted Answer

No. HAROM India supports clients worldwide, with expertise across the major regulatory regions.

Question 15

How secure is my data with HAROM?

Accepted Answer

Data is encrypted in transit and at rest, protected by role-based access controls and two-factor authentication, and every action is captured in a tamper-evident audit trail.

Question 16

Which standards are your systems built for?

Accepted Answer

ICH E2B(R3), GVP modules, 21 CFR Part 11, EU Annex 11 and GAMP 5 — with support for the expectations of EMA, FDA, MHRA, Health Canada, CDSCO and WHO.

Question 17

Do you support regulatory audits and inspections?

Accepted Answer

Yes. We provide end-to-end audit support, mock inspections, documentation review and CAPA preparation, and our systems are validation-ready and inspection-ready by design.

Question 18

What is IntakeIQ?

Accepted Answer

IntakeIQ is a self-service tool for MAHs worldwide. Upload your case documents and get a review-ready, ICH-compliant E2B(R3) XML file and a CIOMS I form — AI-assisted and human-reviewed, with no safety database required.

Question 19

Can I request a demo of your tools?

Accepted Answer

Yes. Request a personalised demo through our contact form or the Request a Demo page, and we'll walk you through the platform and products relevant to you.

Question 20

How is the AI used, and is there human oversight?

Accepted Answer

AI and automation handle the heavy, repetitive work — drafting, coding assistance, checks and report generation. Qualified pharmacovigilance professionals review and approve every safety-critical decision before anything reaches a regulator.

Question 21

How soon can a new project start?

Accepted Answer

We typically respond within 24–48 hours. Once aligned, we can begin documentation, planning and onboarding quickly.

Question 22

Can you support the full product lifecycle?

Accepted Answer

Yes — from PV system and PSMF setup, through ICSR processing, aggregate reports, and signal and risk management, we support the complete lifecycle.

Question 23

How do we get started?

Accepted Answer

Request a demo, submit an RFP, or contact our team directly. We'll understand your needs and recommend the right mix of software and services.

Frequently asked questions.

Understanding pharmacovigilance

About HAROM

Compliance and data

Products, IntakeIQ and AI

Getting started

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