How to Conduct a Pharmacovigilance Risk Assessment

How to Conduct a Pharmacovigilance Risk Assessment

Medication is one of the most powerful tools available for preventing and treating disease and alleviating symptoms. However, all medicines can cause adverse drug reactions (ADRs) despite their benefits. ADRs are harmful and unintended effects of drugs that occur at doses used in humans for prevention, diagnosis, or treatment. Due to their small sample size, pre-marketing clinical trials cannot detect all ADRs. Therefore, evaluating a medicine’s safety requires using it in less selected populations and for more extended practice periods. This ongoing assessment of the safety of marketed medicines is what pharmacovigilance entails. Pharmacovigilance is an essential component of drug safety and regulatory compliance. Pharmacovigilance risk assessment is a systematic approach to identifying, evaluating, and managing the potential risks of using medicinal products. This article will discuss how to conduct a pharmacovigilance risk assessment.

Step 1: Define the Scope and Objectives of the Risk Assessment

To initiate a pharmacovigilance risk assessment, the first step is to define the scope and objectives of the evaluation. Establish the scope based on the medicinal product or category, considering factors like drug indication, dose, administration route, patient population, and duration of use. Additionally, the objectives should be specific and measurable, focusing on identifying potential risks, assessing their severity and likelihood, and developing appropriate risk management strategies. By defining the scope and objectives, the evaluation process becomes more efficient, effective, and focused on all relevant data sources and risk factors.

Step 2: Identify the Data Sources

The next step is to identify the data sources that will be used for the risk assessment. The data sources may include clinical trials, post-marketing surveillance data, spontaneous reports, published literature, and any other relevant sources of information. It is essential to ensure the data sources are reliable and applicable to the medicinal product or product category under consideration. Note that literature monitoring is an ongoing process and requires continuous evaluation of new literature to identify emerging safety issues. Automated tools and algorithms can facilitate this process by quickly identifying and analyzing recent publications and providing alerts for further evaluation.

Step 3: Identify Potential Risks

The third step is identifying potential risks associated with using the medicinal product. This can be done by reviewing the available data sources and consulting with field experts. The risks can be classified into different categories, such as identified, potential, and unknown risks (missed information). It is essential to consider all possible risks, including those that are rare or have not been previously reported.

Step 4: Assess the Severity and Likelihood of Risks

Moving onto the fourth step, the next stage is to assess the severity and likelihood of the risks identified. Risk severity is based on harm potential, while occurrence likelihood determines the possibility of risk. Evaluation methods for risk severity and likelihood include statistical analysis, expert opinion, and risk matrices. These techniques provide pharmacovigilance professionals with an accurate assessment of potential risks.

Step 5: Evaluate the Benefit-Risk Balance

The final step is to evaluate the benefit-risk balance of the medicinal product. This involves comparing the potential benefits of the medicinal product with the risks identified in the risk assessment. The evaluation of the benefit-risk balance should be based on a comprehensive and objective assessment of the available data.


Undoubtedly, pharmacovigilance risk assessment plays a vital role in ensuring drug safety and regulatory compliance. Gathering reliable and relevant data from multiple sources is crucial to conduct a comprehensive risk assessment. In this regard, literature monitoring has proven to be essential for identifying potential safety concerns associated with medicinal products. Pharmacovigilance professionals can make informed decisions about drug safety by staying informed of such problems. Adopting a systematic and objective approach to risk assessment and thorough literature monitoring can help minimize potential risks associated with using medicinal products and improve patient safety. The steps outlined in this article provide a framework for conducting a pharmacovigilance risk assessment. It is essential to ensure that the evaluation is based on reliable and relevant data and that the assessment of the benefit-risk balance is comprehensive and objective.

Looking for Expert Guidance?
Our team is on hand round the clock to guide you on how to enhance your literature screening or to offer consultation on your pharmacovigilance processes.
Unlock the Secrets of the Pharma Industry
Get Your Hands on Our Must-Read Business Case Today!
Follow us
Request a demo
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Have questuions?
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

DrugCard has roots in Ukraine. Support all Ukrainians in their fight against russian aggression