SM-MM-GPV Safety Data Analysis Expert .."R"

SM-MM-GPV Safety Data Analysis Expert

•  MD, pharmacist or other scientist with additional degree in computer science  or  computer scientist or statistician with additional degree in medicine, pharmacology, biology, chemistry or similar  or  computer scientist or statistician with experience in pharmacovigilance or related functions  • Experience in pharmacovigilance or pharmaceutical research and development  • Experience and excellence in working in global and cross-functional teams  • Good knowledge of BSP IT systems and IT standards  • Excellent experience in working with databases (e.g. Oracle) and data analysis and reporting tools (e.g. SQL, PL/SQL, Crystal Reports, Business Objects, SAS)  • Good understanding of statistical and epidemiologic principles and methods  • Good understanding of medical dictionaries (e.g. MedDRA) and drug dictionaries (e.g. WHO DD)  • Good understanding of validation principles and experience in working with validated systems  • Good knowledge of global PV regulations and guidelines as well as good knowledge of BSP products  • Experience with internal audits and external inspections (especially with FDA and EMEA inspections)  • Strong customer focus (e.g. global PV functions, clinical development)  • Excellence in creating innovative solutions and implementing new methods, processes and systems  • Excellent capability to work on and integrate various activities  • Excellence in oral and written English.CLICK HERE TO VIEW APPLY