A Day in the Life of Drug Safety Physician
If you are a healthcare professional – A physician or a dentist – here’s what you need to know about the major roles and responsibilities of a Drug Safety Physician.
MEDICAL REVIEW OF A CASE
After the ICSRs and solicited cases are reported and entered into the system, a Drug Safety Physician would review the case. Well versed in MedDRa coding and narrative writing, along with their prior knowledge in the field of medicine – changes can be suggested by the safety physician while doing a medical review. Many aspects of the benefit-risk profile of the drug in the reported adverse drug reaction may become apparent. for SUSAR ( Serious and Unexpected) cases also. Depending on the capacity of the company/department of pharmacovigilance a safety physician may review 10 or more cases in a day.
CASE PROCESSING
A safety physician will also be involved in different stages of case processing (it can be mainly medical review but not necessarily). In case of lack of complete information of the reported adverse drug reaction, a Drug Safety Physician can generate a query (query generation) to evaluate the seriousness criteria, to assess the benefit risk profile of the drug and to find out the patient’s history. Generating and submitting the report is where the role of a drug safety physician usually ends.
PARTICIPATING IN SAFETY MEETINGS
Discussing with other safety physicians, safety associates, safety managers, medical director and the rest of the entourage of safety professionals is a key for smooth team work in the drug safety department. Understanding and learning of the new medical product, assessing the workflow, being updated with the day-to-day changing regulations and recommendations by the regulatory bodies while maintaining/monitoring the compliance with its other clinical/non-clinical branches is a role played by a Drug Safety Physician in the safety meetings.
