人材紹介Michael Page Japan
コンサルティング - ITシステムコンサルティング
コンサルティング - ITコンサルティング（その他）
IT関連（その他） - その他
As a Senior Consultant, you will support project delivery activities of market leading cloud solutions within Drug Safety and Medical Information verticals of the firm.
* Support global teams in successful implementation and harmonization of Global and Japanese Drug Safety business processes driven by resources who understand both global and Japanese regulations and requirements.
* Participate and manage Argus J configurations (Workflows, reporting rules, Code lists specific to Argus Japan)
* Execute harmonization of data entry conventions between Japan and global. Configuration of Argus Japan to ensure a unified global workflow
* Participate Argus and Argus J - Japan specific reporting requirements, Local and Global lock features, electronic submissions using gateway
* Participate data migrations from legacy systems to Argus Safety specific to Japanese cases
* Responsible for Argus J pre-sales activities such as delivering product demos to prospects/ customers, RFP responses, managing proof of concept or pilot projects.
* Participate as Japanese SME in product certification, localization, pre-sales, content management, configuration, training etc. related to firm's proprietary medical information management system.
* Position involve around 40% of travel across Japan and also to North America and Europe as per the need
* Hands on experience of working on Oracle Argus suite specially Argus Japan
* A degree in Life Sciences, pharmacy or IT with a minimum of 4 years' relevant work experience in Japan Drug Safety or any medical information management system as an end user
* Working knowledge of Argus Japan and electronic submission to PMDA.
* Good understanding of PMDA specific regulations related to Pharmacovigilance
* Understanding Medical Information process and working experience on at least one medical information management software is a plus
* Good understanding and knowledge of FDAs 21 CFR Part 11 and other relevant applicable guidelines and standards is a must
* Excellent interpersonal skills, strong written and verbal communication skill is mandatory
* Ability to interact effectively within and across team environment
* Proficiency in Japanese and English (Business Level)
* Competitive Salary
* Start-up environment
* Chance to travelling globally
* Chance to one of the initial member
* Bilingual working environment
To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Anqi Zhang on +813 6832 8996.
Founded in 2010, a leading global technology service organization, providing pharmaceutical industry-focused services in the areas of Medical Information, Drug Safety, Signal Detection and Management, Clinical Development and Pharmaceutical Sales Management.
The company's global pharmaceutical - information technology focus and functional expertise enable it to provide technology services and consultancy across the drug lifecycle paradigm.
With over 7 years of experience and over 45 clients across the globe, the company has the ability and intellectual capability to deliver large and small projects with finesse and enthusiasm.
|英語能力||ビジネス会話 (TOEIC 735-860)|
|年収||日本・円 600万円 〜 1000万円|