Catching a glimpse at a regular 9 to 5 working day of a Drug Safety Associate.
CASE PROCESSING
A Drug Safety Associate is required right from triage, book-in to case submissions - all the parts of case processing. The role is often more streamlined depending on the magnanimity of the Pharmacovigilance team in an organization or a pharmaceutical company. Otherwise a drug safety associate must be equipped to triage the incoming adverse events based on priority - serious/non serious (and other parameters), must enter data with accuracy and after quality check and medical review go on to generate a report. All along being well versed with the timeline of each case.
ATTENDING SAFETY MEETINGS
The safety associate will also be involved in the safety meeting where personnel from the Pharmacovigilance team would brief each other and discuss the reports, updates, general regulations and other day-to-day activities. Drug safety physicians, medical reviewers, safety lead, safety manager and director may also be part of these meetings. Usually when working in teams - it’s a group effort with each particular case and also with the case influx from clinical trials. Discussions on risk management, aggregate periodic reporting. coordinating and meeting up the Clinical research team is also one of the roles in the life of a Drug Safety Associate.
LEARNING THE ASSIGNED PRODUCTS
Incoming daily ICSRs and other solicited reports are a given in the life of a drug safety associate. With more pharmaceutical companies in the healthcare industry branching out to CROs - newer products and drugs in the market need to be assessed. Good Pharmacovigilance practice comprises credible and accurate monitoring as well as analysis of all Medical products including - herbals, traditional and complementary medicines, blood products, biologicals, medical devices, vaccines for use of public safety. Learning and understanding the medical product in an ongoing project guides the safety associate to be apt decisions at all stages of case processing.
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