Thomas Chatzopoulos

Development of an outsourcing strategy within Pharmacovigilance Implementation of preferred provider partnership with offshore vendor Governance and management of offshore vendor Lead global team to negotiate, implement and oversee Pharmacovigilance Agreements/Safety Data Exchange Agreements, worldwide Administrative EU Site Head function for Case Management

Line Management responsibility for Regional Center EU for the Safety Operations Teams: Compliance Team, Clinical Study Team, Safety Operations Germany, Safety Operations Region, Safety Operations Literature Oversee, coordinate and manage the teams related to Quality monitoring, AE collection in clinical trials, ICSR processing for the EU Region, Literature review

Project lead in the change-over of responsibility for pharmaceutical technical complaints from Pharmacovigilance to Quality Assurance Implementation and conduct of Pharmacovigilance audits, System PV audits, License Partner audits and vendor audits Preparation, coordination, support in Pharmacovigilance Inspections Project management for the implementation of the Novartis Quality Manual

Writing and training of Standard Operating Procedures (SOPs) Organise basic areas of an international Pharmacovigilance System Integration of affiliates within headquarters Pharmacovigilance System Drug safety contact person for third parties and in inspections Implementation of contract management for safety information exchange Developing a drug safety contract database

Processing of adverse events from spontaneous sources and studies Medical-scientific assessment of drug risks Expedited and periodic reporting to health authorities Responsible to fulfil national and international reporting obligations Planning and conduct of drug safety part in clinical studies Answer drug safety relevant requests to health authorities Training of sales representatives Scientific support in the acquisition of a safety database