Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. In general, Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to: identifying new information about hazards associated with medicines preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: “A response to a drug which is noxious and unintended, and which occurs at doses normally use for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
Drug Safety Associate manage activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products.
The DSA ensures timely submission of reports regulatory agencies in accordance with applicable regulations and that all inquiries from the FDA and other drug regulatory agencies are responded to in a timely manner. The DSA will respond to inquiries from health care professionals, consumers, and company personnel regarding safety issues with marketed products; prepare periodic comprehensive written reviews of all assigned AEs; identify potential sources of product litigation, extract AE data from various clinical trial cases and spontaneous sources; manage case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries; and ensure proper coding (MedDRA) into the global AE database.
Who hires Pharmacovigilance Professionals?
People trained in Pharmacovigilance can find excellent work opportunities in following organizations: