Summary report -2
This report consists of details on the job duties that I performed in Abbvie, Inc. as Drug Safety Consultant from Nov 2nd, 2017. I have incorporated the company’s main motive to protect and improve the quality of life of the people into my daily responsibilities. The primary task I was assigned after the company’s mandatory training on various tools and their application is safety surveillance. Safety surveillance is very important as it provides a structured and consistent approach throughout a product’s life cycle to weigh positive effects against the negative effects which includes expected and unforeseen effects either in context of an individual patient or for the public as a whole. I was asked to identify the undesirable …show more content…
I also got well versed with the signal identification methodologies and assessment of safety concerns and any risk minimization strategies. My priority role is to conduct safety monitoring in which activities are designed to identify previously unknown effects of drug products or new aspects of known effects in order to harness such effects if beneficial or prevent or mitigate them if harmful. I have obtained sufficient information from various sources including observations and experiments which suggests a new potentially casual association or a new aspect of a known association between an intervention and an event or a set of related events which are either adverse or beneficial, that is sufficient to justify the action. This data once obtained is validated to support the identified signal. Evaluation of signals include review of information from cumulative data from the global safety database( HLGT/SOC/PT), other available sources are clinical trial database, scientific literature reviews, epidemiologic studies, cross sectional studies and interventional
This report consists of details on the job duties that I performed in Abbvie, Inc. as Drug Safety Consultant from Nov 2nd, 2017. I have incorporated the company’s main motive to protect and improve the quality of life of the people into my daily responsibilities. The primary task I was assigned after the company’s mandatory training on various tools and their application is safety surveillance. Safety surveillance is very important as it provides a structured and consistent approach throughout a product’s life cycle to weigh positive effects against the negative effects which includes expected and unforeseen effects either in context of an individual patient or for the public as a whole. I was asked to identify the undesirable …show more content…
I also got well versed with the signal identification methodologies and assessment of safety concerns and any risk minimization strategies. My priority role is to conduct safety monitoring in which activities are designed to identify previously unknown effects of drug products or new aspects of known effects in order to harness such effects if beneficial or prevent or mitigate them if harmful. I have obtained sufficient information from various sources including observations and experiments which suggests a new potentially casual association or a new aspect of a known association between an intervention and an event or a set of related events which are either adverse or beneficial, that is sufficient to justify the action. This data once obtained is validated to support the identified signal. Evaluation of signals include review of information from cumulative data from the global safety database( HLGT/SOC/PT), other available sources are clinical trial database, scientific literature reviews, epidemiologic studies, cross sectional studies and interventional