Clinical Research and Pharmacovigilance Courses create Efficient Drug Safety Associates

Significance of Drug Safety Associate

A Drug Safety Associate is a significant part of the pharmacovigilance industry. A Drug Safety Associate mainly monitors the safety of pharmaceutical drugs. Their role in the industry is of great significance as they evaluate and prevent adverse reactions. In patient’s .They analyze clinical trial data, write reports and determine whether specific pharmaceutical drugs are safe for sick patients. Once, pharmacovigilance professionals declare that a particular drug or device is safe for patients. These drugs enhance the quality of the life of patients all over the world. Given below are the different tasks that Drug Safety Associates execute in the pharmacovigilance industry. Clinical Research courses give you an overall understanding of the tasks of Drug Safety Associates

Processing an Adverse Event

The role for a Drug Safety Associate begins after the alert of a Serious Adverse Event.  These professionals immediately start completing the necessary tasks involved in processing an event. Suppose, there is a life threatening case or a death, Drug Safety Associates are given 1-2 days to process the essential information. There may be other cases such as hospitalization, significant disability, congenital anomaly. In this case, the Drug Safety Associates would take 2-7 days to process the event.  The best clinical research training institutes give students an insight into several adverse events during clinical research courses.

Reporting the Cases to Regulatory Authorities

In this short period of time, DSAs usually have to classify the case, ensure all the key information is correct, enter the information in the database and send the case for quality review. Furthermore, they should proceed to the medical review stage and create queries to obtain information in order to accurately assess the role of the study drug on the event. Finally, it’s important to deliver the case to the regulatory team so they can submit it to the relevant authorities such as the FDA or EMA and to investigators, ethics committees and IRBs. This process can be more complex because DSAs are working on multiple projects with different Sponsors.

https://www.technobridge.in/clinical-research-course.html

Collaborations with Other Teams

Drug Safety Associates receive a variety of support both from their own study team colleagues and the other departments. They have internal interactions with the Drug Safety Physicians (DSPs) for medical assessment of safety cases. Furthermore, DSAs can also have external interactions with other departments such as the data management team consisting of the Clinical Data Lead and Project Manager roles for eCase Report Form enquiries. Similarly, they report to the clinical operations team comprising of Clinical Trial Assistants, Clinical Research Associates, Clinical Trial Managers and Project Managers who act as the main point of contact for the SAE follow-up. The medical affairs team  consisting of Medical Affairs Specialists, Medical Affairs Managers  help detect non-reported SAE, while the safety regulatory group (Drug Safety Associates, Project Managers) submit processed cases to the competent authorities and other required recipients. Clinical Research Courses prepare all clinical research professionals for the roles in their industry.

In a nutshell, the role of a drug safety associate is of great significance in the clinical research and pharmacovigilance industries. After completing their clinical research courses, they play an important role in determining the safety and efficiency of drugs and devices. Apart from that, they process Adverse Events and report them to regulatory authorities.

https://www.technobridge.in/