Alis Burciu

Responsible for the conduct of local affiliate pharmacovigilance activities in accordance to regional and national regulatory requirements and internal company procedures: - monitoring, collection, evaluation and recordation of adverse drug reaction reports from health care professionals, consumers, literature and other various sources; - timely submission of expedited and periodic safety reports to competent regulatory authority and ethics committees; - provision of training to company personnel

Overall purpose of the job is to participate in preparing and conducting the research program within the Local Operating Company. Main tasks and responsibilities are: - to develop and review the Study Concepts and Protocols particularly with regard to operational feasibility and conduct the Site Selection and Feasibility process, - to drive the preparation of CTA for submission to the HA, - to prepare study materials, - to ensure that investigational staff is trained on AE/SAE Reporting Procedures,

Radiology