Stephen Douglas is a biologist who joined the pharma industry in 1978 and has worked with medium to large pharmaceutical companies.
His initial 3 years were in sales and marketing prior to a move to clinical development for Phase III and Phase IV clinical trials, subsequently including all phases from I to IV. He has been project director for small studies and large multinational safety studies.
For over 15 years he has specialized in Pharmacovigilance. For the last ten years he has worked in senior roles within the Clinical Research Organization (CRO) sector including eight years with PAREXEL. As a consultant he has specialized in the development of compliant Pharmacovigilance systems, including Pharmacovigilance and risk management planning at the time of application for marketing through to supporting inspection readiness, auditing and training in the post-marketing environment.
As a contracted Qualified Person he has been directly responsible to EEA regulatory authorities as the single point of contact for safety issues for marketed products.