The process of collecting safety profile of drugs during or after clinical trials is never complete but is a continuous endeavor. Generally thousands of patients are subjected to clinical trials however in some cases for example if drug gets orphan status few hundred are subjected to drug. In statistical viewpoint, if 1,000 clinical trialparticipants were subjected to the drug and did not have a heart attack, all we can say is that the true occurrence of heart attacks with this drug (at the 95% confidence level) is not greater than 1 in 333. So obviously the role of the Physician who assesses the safety information is important and must supplement the work of the clinical research physicians handling the clinical development program who are obviously concentrated on efficacy measurements and initial risk-benefit analysis.
Throughout clinical trials, the investigators need to report all serious adverse events (SAEs) to the sponsor as per time frame given in protocol. The sponsor must sort out the reports on whether they are felt to be probably because of the drug and, in that case report them quickly to the regulatory authorities. The company is expected to aggressively monitor, follow up and evaluate all safety problems and adverse events seen throughout the trials. This is where Physician performs a major role. He or she should look at all the adverse events and see if there is a pattern.
Some conditions like Stevens Johnson Syndrome are very likely to be because of drug effect and other for example myocardial infarctions in middle age and diabetics are impossible to ascribe to a drug effect. This is where the physician has to perform the role of clever detective and evaluate all the data, usually case by case, to look for the needle in the haystack. One should have good understanding of medicine, be a logical thinker and be capable to come to logical and defensible conclusions dependent on incomplete data or on blinded cases. It is by no means a simple job. In addition, the Drug Safety Physician must submit Periodic Safety Update Reports (PSURs) to regulatory authorities by assessing the totality of the safety data.
Job Duties of Drug Safety Physician
- Perform review and evaluation of individual case safety reports received from clinical studies, spontaneous and solicited reports.
- Identify regulatory report potential of cases received from clinical studies, spontaneous and solicited reports within given therapeutic team and throughout all products/sites, as essential, and in a well-timed fashion.
- Carry out triage of cases and identify severity and relatedness throughout products as given.
- Evaluate and verify proper selection of adverse events from source documents, determine proper MedDRA code, evaluate labelling, review narrative.
- Attain and maintain present knowledge of product portfolio and safety profiles for products throughout therapeutic segment.
- Carry out evaluation of litigation cases throughout products as assigned.
Drug Safety & Pharmacovigilance is not for everybody, but it can be an essential part in developing your career as an Industry physician and according to me it’s significance in the industry will keep on to grow.
