Alis Burciu
Angestellt, Senior Pharmacovigilance Associate, Bristol-Myers Squibb Romania
Basel, Schweiz
Werdegang
Berufserfahrung von Alis Burciu
Bis heute 15 Jahre und 3 Monate, seit Apr. 2009
Senior Pharmacovigilance Associate
Bristol-Myers Squibb Romania
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
2 Jahre und 7 Monate, Sep. 2006 - März 2009
Medical Affairs Associate/Local Safety Administrator
Janssen-Cilag Johnson&Johnson d.o.o Romania
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,
Ausbildung von Alis Burciu
6 Jahre und 3 Monate, Jan. 2003 - März 2009
Radiology
Medicine University "Carol Davila" Bucharest Romania
6 Jahre, Okt. 1995 - Sep. 2001
General Medicine
Medicine University "Carol Davila" Bucharest Romania
Radiology
Sprachen
Englisch
Fließend
Französisch
Grundlagen