Risk Management Process in Pharmacovigilance
Risk
Risk represents any kind of uncertainty that can improve or reduce the ability to achieve your objectives. It can take many forms, including risks affecting projects, finances, security and privacy, and the environment
The Role of risk management in pharmacovigilance
The Risk management system is a set of Pharmacovigilance activities and interventions which are designed to identify, assess and prioritize minimize the risk of a medicinal product throughout its life cycle to improve its benefit/risk balance. The basic principle of risk management is to confirm that the benefits of a medicinal product exceed the risk by an achievable margin for the patient or to a target population as a whole.
The steps of the Risk Management
Identify the risks.
Analyze the likelihood and impact of each.
Prioritize risk based on enterprise objectives.
Treat/Respond to the risk condition.
Monitor risk management results.
Identify the risks
First, identify all the risks your organization might encounter in its operating environment. There are many types of risk assessment, but generally, this process is performed routinely. To start a risk assessment, examine the factors in your organization and environment. Anything that can harm your organization should be on your radar, including natural disasters, technological risks, and single point of failure (SPOF) risks. Consider creating a risk register that serves as an ongoing database of each project’s potential risks. This will help you and your team manage current risks.
Analyze the likelihood and impact of each
After risk identification, you perform risk analysis. Some risks can bring your business to a standstill, while some will only be minor inconveniences. Analyze each threat and determine its scope and potential disruption. You can then establish a link between the risks and different factors within your organization. Specifically, this will help you understand how many businesses functions the risk affects. The greater the number of functions, the more severe the risk.
Prioritize risk based on enterprise objective
Next, rank and prioritize each risk depending on its severity. This allows the risk management team to see and understand your organization’s total risk exposure. For example, risks that will lead to minor inconveniences should be a lower priority, while risks that can cause catastrophic losses should be at the top. Additionally, you should figure out your risk profile, your risk appetite and risk tolerance.
Treat/Respond to the risk condition
Develop a risk treatment plan to eliminate each risk as much as possible. Starting with the highest-priority risk, you and your team should work to solve the threat so the risk no longer threatens your organization. A good starting point is to connect with the respective experts of each field to which the risk belongs
Your risk mitigation strategy should include.
Avoid the risk
Reduce the risk
Share the risk
Accept the risk
Monitor risk management results
Regularly monitor, track, and review your risk mitigation results to determine whether your initiatives are adequate or if you need to make any changes. Your team will have to start over with a new process if the implemented risk management strategy isn’t practical. Avoid impulsive reactions and get into “firefighting mode” to rectify problems. Instead, a clear, calm perspective will make you better equipped to minimize the harm of project threats
References
https://reciprocity.com/blog/5-step-risk-management-process/
https://www.intechopen.com/chapters/17372
https://www.techtarget.com/searchcio/feature/Risk-management-process-What-are-the-5-steps?amp=1
Student Name: Abhishek
Student ID:218/1222
Qualification: B. Pharmacy
e-Mail ID: abhishekgouli1@gmail.com
Comments