Senior Consultant, Argus J is a multi-disciplinary role that supports project delivery activities of market leading cloud solutions within Drug Safety and Medical Information verticals of Techsol Corporation.
- Support global teams of Techsol 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 Japense 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 Techsol’s medical information management system – MedInquirer
- Position involve 40% to 50% of travel across Japan and also to North America and Europe as per the need
The job applicant should possess:
- 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 Japan (native) written and spoken skills is a must
If you are interested in this position, please forward your CV to firstname.lastname@example.org
|Job Category||Sr. Consultant|