Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
Physicians have a crucial role to play in assessing and maintaining the safety profile of the drug. As for the new drugs, the complete safety profile is not established from the clinical trials. Pharmaceutical companies or marketing authorization holders (MAH) have to conduct ongoing pharmacological surveillance on the marketed drug.
As the clinical trials are designed to evaluate both the efficacy and safety profile of the investigational drug but tend to lean towards efficacy component, the role of the Drug Safety Physician who evaluates the safety information and assess the benefit-risk profile of the drug is important.
In clinical studies, the sites are expected to report all Serious Adverse Events to the sponsor within 24 hours of occurrence. The marketing authorization holder has to assess the causality of such events and determine if the reported events have to be expedited to the regulatory authorities. the drug safety physician with his clinical knowledge of the disease and the drug/event combination has a significant part in this process of case assessment.
Safety physicians evaluate each drug event combination on a case by case basis and also perform aggregate analysis of similar cases (aggregate reporting such as PSUR/PBRER, IND annual reports) to notice a pattern or a causation trend that is defined as a signal. In signal detection, the drug safety physician exercises his medical knowledge to notice any alternative etiologies to contribute to the adverse events and if not, the pattern is validated for further assessment.
Safety physicians have a role in mitigating the risks identified during the clinical trials and post-marketing period of the drug. They become engaged in the process of identifying, implementing, and evaluating such risk minimization methods, which may be required for the approval of the drugs by the regulatory authorities such as FDA, EMEA, and MHRA.
Drug Safety physicians are an integral part of any pharmacovigilance plan. They work in a matrix environment with other departments such as clinical operations, clinical, data management, biostatistics, regulatory, within the pharmaceutical companies.
Why certificate course in Advanced drug safety and pharmacovigilance from Medipharm solutions?
Medipharm solutions provide the training necessary to assist professionals in bridging the gap between their qualifications and skills needed to secure a career in the pharmaceutical industry. The Institute offers this by focusing attention on deploying cutting edge training and testing certification methods. Empowering professionals with the current market place needs by building industry-standard course curriculum. Most important of all, to make you a trained professional with job-readiness skills and knowledge.
Our course coaches who designed this curriculum are pharmacovigilance leaders in the pharmaceutical world who are passionate about guiding you in your drug safety career path.
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