Dr. Scott Sykes joins MedSurgPI

Dr. R. Scott Sykes, MD has more than 30 years of experience in clinical research and pharmacovigilance experience. This unique experience includes clinical research in the areas of respiratory (inhaled beta-agonists, corticosteroids), GI, and oncology (serotonin antagonist). Pharmacovigilance experience includes pre and post marketing experience in almost all therapeutic areas, including all aspects of individual and aggregate safety data review, safety-related signal detection, risk-management, product labeling, periodic reporting (PADER, PSUR, DSUR, etc.), training, staff development, FDA presentations and negotiations, and management of teams ranging from 5 to 80 staff members. Management experience includes VP North American Product Surveillance (Glaxo Wellcome), Chief Medical Officer/VP (Salix), VP Corporate Drug Safety (Schwarz Biosciences), and Head Medical-Safety Evaluation (Merz North America).

As a consultant Dr. Sykes has served in a number of capacities for pharmaceutical companies and CROs throughout the industry, including audits, gap analyses, safety data review for the purpose of labeling updates/additions, developing internal pharmacovigilance departments with necessary adverse event database installation, standard operating procedures, working practices, audit/legal protection strategies, safety-related data review procedures and documentation, and strategic overview of existing departments.

Dr. Sykes received his BA in Chemistry at the University of North Carolina-Charlotte, his Medical degree from the University of North Carolina – Chapel Hill and completed internship at Shands Hospital – University of Florida in Gainesville, Florida. 

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