Pharmacovigilance process

As the world advances, the need and desire for better medication and drugs become the priority of many thus the pharmacovigilance process.

Medicines and vaccines have transformed the prevention and treatment of diseases. All drugs undergo rigorous processes for safety and efficacy through clinical trials before they are approved for use.

I believe is time you learn about the pharmacovigilance process. However, before we proceed, let’s take a look at what pharmacovigilance is.

Pharmacovigilance is coined from the words pharmakon (Greek for drug) and vigilare (Latin for to keep watch).

It deals with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.

A drug adverse effect is any response to a drug that is unintended, including lack of efficacy.

However, the clinical trial process involved in pharmacovigilance implores studying these products in a relatively small number of selected individuals for a short period of time.

Before a medicine is authorized for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions.

Let us dive into the business of the day; the Pharmacovigilance process.

What is the pharmacovigilance process?

The pharmacovigilance process involves 4 stages namely;

  1. Detection
  2. Assessment
  3. Understanding
  4. Prevention


Pharmacovigilance starts with safety information that comes from different sources such as solicited and unsolicited reporting.

SOLICITED SOURCES– RECEIVED AS A RESULT OF TARGETED DATA COLLECTION (i.e, establish a channel to collect the adverse effects)

Clinical trials: phase I-III and post-marketing (non -conventional and interventional studies) and trials.

Registries: organized systems with predetermined scientific, clinical, or public health purposes.

personalized programs for nonregistering drug administration.


  • Consumers and patients (regardless of medical information )
  • Healthcare professionals
  • Regulatory authorities
  • literature reports
  • license partners
  • lawsuits against medicinal products: legal cases
  • Internet and other media sources


After the collection of adverse events, an assessment of ICRS is conducted.


  1. TRIAGE:  the triage phase of the potential adverse event report involves establishing the validity of an icsr. A valid ICSR should mandatorily possess the below-mentioned format

A: an identifiable patient

B: an identifiable reporter

C: a suspect drug

D: an adverse event


Every medical product company maintains its own safety database

After case validation, the safety associate enters the safety information

the further process in data entry includes

  • Seriousness determination
  • Coding of adverse events using MedDRA
  • Casualty assessment
  • Labeling assessment
  • Clear and concise narrative writing

It involves the raising of queries to the reporter if any additional information is required and also clarifying the discrepancies (if any) in the safety data.


Safety physician reviews safety information that emphasizes casualty, seriousness, labeling, and provide the company pharmacovigilance comments.

Medical review is the first level step in signal detection activities.


The completed ADR report is submitted to the respective regulatory authorities.


Aggregate data review is performed to understand the drug safety profile using the following documents:

periodic benefit-risk evaluation report (pbrer): all spontaneous and clinical trial cases reported during the review period are discussed in detail and benefit-risk analysis is performed.

specific adverse reaction follow-up questionnaires are used to get structured information on reported suspected adverse reactions for the important risk.

  • Signal analysis- Every MAH has a proper signal management system and performs the signal analysis.
  • Risk management plan (rmp)
  • Development safety update report (DSUR)

All the above safety documents are periodically submitted to the regulatory authorities.


1 performing risk minimization activities I.e to update the summary of product characteristics, patient information leaflet, labeling, and packaging of the medicine and legal status of the medicine.

  1. monitoring risk minimization activities.

Components of pharmacovigilance

Below are the cardinal components of pharmacovigilance that assist different pharmaceutical companies in decision making

  • Adverse Event Case Management including expedited reporting
  • Aggregate Reporting
  • Signal Intelligence
  • Risk Management

Pharmacovigilance importance

From the definition of pharmacovigilance, one can easily deduct the advantages, however, we bring to you a better explanation of the importance.

Adverse Drug Reactions (ADRs) are among the top ten leading causes of death in most countries. Drug safety monitoring is a risk mitigation exercise in which the ADRs caused by therapeutic drugs, biologicals, or devices can be explored, prevented, or minimized. It has become a key aspect of effective clinical practice in many countries.

Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases is determined, which is important for early drug discovery to PV.

Pv helps to improve quality and regulatory compliance while reducing cost and also, increasing the variety of data sources.

Simplify case intake and processing by leveraging mobile and digital technologies (making it faster, more efficient, and cost-effective)

Moreover, PV has traditionally been involved in mining spontaneous reports submitted to national surveillance systems.

The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums.

Adverse events reported by the PV system potentially benefit the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enabling easy contact with reporters electronically.

Pharmacovigilance tools

  • Data mining
  • Geographic Information Systems (GIS)
  • Text and information mining
  • Visualization tools

Data Mining

Among the pharmacovigilance, tools is data mining. It comprises;

  • Descriptive modeling
  • Predictive modeling
  • Prescriptive modeling
  • Disproportionality methods

Geographic Information Systems (GIS)

GIS can be used to identify geographic trends over time, perform surveillance, visualize the locations of patients and determine if there are clusters of specific types of customer or patient experiences.

Text and information mining

Text and information mining help to detect specific text patterns or combinations, as well as trends.

Visualization tools

Visualization analytics encompasses the use of pictures and graphics to facilitate the understanding of complex data relationships by displaying data in a visually meaningful way.

A very useful and fundamental instrument for visualizing patterns in the environment of multiple-source data integration. Widely used in healthcare data analytics.


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