Top Pharmacovigilance Interview Questions & Answers | Clinoxy

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Pharmacovigilance is the science of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems.

It ensures patient safety, monitors drug performance after marketing, and helps identify previously unknown side effects.

• An ADR is a harmful or unintended response to a drug taken at normal doses.

An adverse event is any unwanted occurrence after taking a drug, while an ADR has a proven relationship with the drug.

To improve patient care, ensure drug safety, detect new adverse reactions, and support regulatory actions.

An SAE is an event that results in death, hospitalization, disability, or is life-threatening.

It is the process of determining whether a drug caused or contributed to an adverse event.

Clinical trials, spontaneous reports, scientific literature, and post-marketing studies.

WHO coordinates global drug safety monitoring through its Uppsala Monitoring Centre (UMC).

They are systems where healthcare professionals or patients voluntarily report suspected ADRs to regulatory bodies.

ICH E2A provides international guidelines for clinical safety data management, including expedited reporting.

ICH provides global harmonized guidelines, while GVP (Good Pharmacovigilance Practices) is specific to the European Union.

MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology used for coding adverse events.

It collects and manages information on suspected adverse reactions in the European Economic Area.

The FDA monitors drug safety in the U.S. and regulates post-marketing surveillance.

The FDA monitors drug safety in the U.S. and regulates post-marketing surveillance.

The FDA monitors drug safety in the U.S. and regulates post-marketing surveillance.

It involves identifying new or rare adverse events from various data sources.

An RMP outlines how potential risks of a drug will be identified, assessed, and minimized.

It stores and manages all adverse event reports for analysis and regulatory submissions.

1. Identifiable patient
2. Identifiable reporter
3. Suspect drug
4. Adverse event

It is the process of prioritizing incoming cases based on seriousness and reporting timelines.

Narrative writing is summarizing the event details, timeline, and outcomes in a clear, logical story format.

Expectedness refers to whether an ADR is already known, based on the product label or Investigator’s Brochure.

Follow-up collects additional missing or unclear details to ensure accurate and complete case reporting.

It is identifying and removing duplicate case entries in a safety database.

Expedited reports are sent quickly for serious or unexpected events; periodic reports summarize all events over a period.

A SUSAR is a serious reaction that is both unexpected and suspected to be caused by the drug.

Usually within 7 calendar days for fatal/life-threatening cases and 15 days for other serious cases.

It ensures accuracy, regulatory compliance, and credibility of safety data submitted to authorities.