Drug Safety Associate
- Freelancer N
- 5 to 10 Yrs
- Multinational, Abroad
- 11 months ago
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Job Description
A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once theyre 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, its 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.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Pharmacist / Medical RepresentativeBio Tech / R&D / Scientist
Functional Area: Not Applicable
Role/Responsibilies: Drug Safety Associate
Contact Details:
Company: Redmil Business MallLocation(s): Multinational, Abroad
Keyskills: verbal it analytical problem solving project management written excellent communication team working mathematical attention to detail
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