Dr. Joseph has more than 25 years of drug safety experience in all phases of drug development and marketing from his work in the pharmaceutical industry, as an independent consultant, and as a clinical study medical monitor.   He has published widely on medical information management and drug safety surveillance techniques, and he is considered the leading authority on MedDRA and autoencoding.  His medical information management projects led to pharmacoepidemiological publications such as the validation of diagnoses in Medicaid and other longitudinal databases.

His involvement with MedDRA began in 1993, as the expert medical informatics advisor on the FDA's Standardized Nomenclature Project.  He developed efficient methods of computer-assisted classification while programming the first industry autoencoder (PIRIcode™) in 1988, and coined the word autoencoding.  His techniques were widely adopted after publication in the Drug Information Journal.  His current medical informatics work focuses on the design and implementation of procedures to support consistent clinical classification, comparison, pooling, and assessment of data across multiple MedDRA versions.

Dr. Joseph's industry drug safety background includes serving as the Senior Director for Drug Safety at Agouron Pharmaceuticals and as the Associate Director for Medical Epidemiology at Burroughs Wellcome Co. (BW Co.).  At Agouron he was responsible for development of a pharmacovigilance group, selection and implementation of a new adverse event management system, advising clinical projects on safety issues, periodic database audits, medical reference development, coding conventions, and staff training.  Significant responsibilities at BW Co. included Task Force leadership of the first industry Treatment IND (AZT™, 1987), direction of post-marketing surveillance studies, development of a quality assurance team, the creation of automated and hardcopy drug safety references for reliable risk analysis (syndrome definition, trend analysis, automated periodic reporting, and signal generation), and management of worldwide adverse drug experience reports on all BW Co.  marketed drugs.

As an independent drug safety consultant, Dr. Joseph advised pharmaceutical companies in the US and Europe on global clinical database specifications, surveillance unit organization, the design of data collection forms, accurate classification of adverse events and concomitant medications, event monitoring, signal recognition, and the creation of labeling terms from coded data in clinical study databases.

During almost four years as a medical monitor in a CRO, he was responsible for studies that included Attention Deficit Hyperactivity Disorder; Blepharospasm; Cervical Dystonia; Diabetic Peripheral Neuropathy; Fibromyalgia; Generalized Anxiety Disorder; Insomnia; Lennox-Gastaut Syndrome; Major Depressive Disorder; Pediatric Constipation; and Restless Legs Syndrome.

Dr. Joseph also developed the Adverse Drug Event Management PIRIcourse™ to provide practical industry training in pharmacovigilance.