Global Pharmaceutical industry｜大手外資系製薬会社

Pharmacovigilance Data Analyst｜ファーマコビジランス データアナリスト
■The main purpose is to act as a business and IT expert in all areas where Pharmacovigilance (PV) data analytics is required, e.g. product safety, PV workload, process and compliance analytics, qualitative and quantitative signal detection and management, extrapolation and prognosis.
■To translate complex medical and managerial business demands across all PV areas into data queries and requirements for IT solutions while understanding authority regulations in the PV and GxP domains, related global PV processes, available databases and their contents plus operational IT aspects.
■Project and service management concepts must be applied in order to provide project contribution and implement service enhancements.
■Direct support of inspections and audits and advise to product experts and PV management for the optimal use of data from different internal and external sources, for the use of related reporting tools and medical dictionaries for safety and process analytics.
■Contributions to SOP creation, service development and improvement, tool development, implementation, maintenance and validation.

■Preferably a degree in computer science with additional qualification in statistics, medicine, pharmacology, biology, chemistry or similar experience in pharmacovigilance or pharmaceutical research and development.
■Minimum ５ years experience in working with databases (e.g. Oracle) and data analysis and reporting tools (e.g. SQL, PL/SQL, Crystal Reports, Business Objects, SAS, Spotfire, Excel).
■Good understanding of software development principles, quality frameworks such as Six Sigma, ISO 9001, TQM, KTQ and service management frameworks such as ITIL.
■Experience with audit and inspection support
■Nice to have Good understanding of statistical and epidemiological principles, medical dictionaries (e.g. MedDRA), drug dictionaries (e.g. WHO DD), GxP principles
■Excellent oral and written communication skills - essential in English, Chinese and if possible Japanese language
■Strong customer focus as well as high degree of interpersonal and intercultural skills, high passion for working together with foreign countries and cultures, ability to develop others, cooperate and work within a multi-national team which is distributed among all major time zones

Working location: Western part of Japan(Osaka)｜勤務地：西日本（大阪）