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What does a Drug Safety Associate (DSA) do?

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market. Using standardised guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to the pharmacovigilance department.

Being a significant part of the pharmacovigilance and safety services (PVSS) department, a Drug Safety Associate (DSA) is a key job profile for drug safety management in clinical trials and post marketing surveillance (PMS).

Often, outside of safety services, this job role is relatively invisible or misunderstood. To learn about the importance of this role, we spoke to Karina Espinoza and Jessica Martinez, talented DSAs at ICON, to give us insight into the complex role of the DSA — one that involves multiple unique tasks which ensure any new drug or device is safe and will improve the quality of life of people worldwide.

What a Drug Safety Associate job entails

Once a drug has been marketed the work for a DSA begins after. As soon as an alert of a serious adverse event (SAE)  is raised the clock starts and sets into motion the necessary tasks that need to be completed to process the events.

The tight timeline

In a life-threatening case, or in the case of death, DSAs are given 1-2 business days to process the necessary information and pass it onto other teams. Other medical cases including hospitalisation, significant disability, congenital anomaly or other medically important events require this process to be completed in 2-7 days.

In this short period of time, DSAs usually have to classify the case, ensure all the key information is present, enter the information in the database and send the case to quality review. Furthermore, they should proceed to the medical review stage and create queries to obtain as much information as they can 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.

Coordinating on multiple projects

This seemingly linear process can be more complex than it appears when you consider that DSAs are working on multiple projects at once, each with different Sponsors. In addition, the timelines may depend on the study specifications previously agreed on with the Sponsors, and compliance must be guaranteed.

The support and training

Fortunately, DSAs 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) from PVSS for medical assessment of safety cases. Furthermore, DSAs can expect external interactions with other departments such as the data management team (including Clinical Data Lead and Project Manager roles) for eCRF enquiries.

Similarly, they report to the clinical operations team (consisting 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 (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.

Why should you become a Drug Safety Associate?

In 2019, the global clinical trials market was valued at $46.8 billion and is predicted to continue at a compound annual growth rate (CAGR) of 5.1% over the next seven years. Although the outbreak Covid-19 has interrupted the progress of clinical trials and shifted much of workforce towards a remote model, the industry’s drive to deliver a vaccine against coronavirus will create the momentum needed to support the market’s growth. With the clinical trials market set for a promising future, a DSA job offers great career prospects and the opportunity to work in a highly rewarding role that improves the lives of patients.

What skills do you need?

The work of a DSA is fundamental to the smooth running of clinical trials and PMS. The role requires resilience, adaptability, excellent time-management and the ability to prioritise and tackle high workloads; these are the skills that employers will look for in digital interviews.

A case study

As her workload grew, Karina spoke of how the team at ICON grew with it, which transformed their department into a heterogeneous team. The workplace became more collaborative and allowed people the opportunity to develop into lead management roles and share their expertise and knowledge with new members. Through this, the team found new and better ways to enhance processes. Karina explains this progression to us:

“In 2015, the Mexico Office only had two members in the PVSS department, but now we have 20 active members with more than 70 assigned studies, working on case processing to deliver new and better drugs or devices for people’s health and wellness.”

The improvements made in her department started with the internal and external Sponsor procedures which were streamlined. Added personnel allowed for more balanced workloads which created a goal-oriented and motivated team.

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ICON is one of the world’s largest Clinical Research Organisations, that works with the world’s top pharma, biotechnology and medical device companies in helping them to bring their new medicines and medical devices to market faster. We’re looking for talented and motivated individuals to join our teams, and in return for your dedication, we offer competitive salaries with great benefits and training opportunities. To progress your career in safety services, apply for a Drug Safety Associate job with ICON today.

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