This is a remote position.
Argus Configuration Specialist – Japan
• Location: Onsite – Japan
• Experience: Minimum 12+ Years
• Language Requirement: Business Proficiency in Japanese (JLPT N2 or above preferred)
• Availability: Immediate Joiners Preferred
• Relocation: Candidates with the right experience and Japanese language proficiency willing to relocate to Japan will also be considered.
About our client:
Our client brings together Pharmacovigilance expertise, third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets.
Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets.
Requirements
Role Overview:
We are looking for an experienced Argus Configuration Specialist with strong Pharmacovigilance system knowledge and Japanese language proficiency, ready to take on a leadership role in system architecture and configuration for our pharma clients in Japan.
Key Responsibilities:
- Lead configuration, installation, validation, and customization of Oracle Argus Safety systems.
- Translate user and business requirements into technical specifications and configuration designs.
- Perform Business and System Configuration of Argus modules for both standard and custom workflows.
- Design, configure, and validate Aggregate Reports and Periodic Safety Update Reports (PSURs).
- Perform and support System Integration Testing (SIT) and User Acceptance Testing (UAT).
- Ensure compliance with international regulations and standards including 21 CFR Part 11, ICH, GxP.
- Liaise with Japanese stakeholders, bridging communication gaps with fluent written and verbal skills.
- Support global PV implementation or upgrade projects with emphasis on Japan-specific regulatory norms.
- Provide ongoing maintenance, upgrades, and technical documentation.
Required Skills:
- 12+ years of strong experience in Argus Safety configuration and PV systems implementation.
- Proficiency in SQL / PL-SQL for data extraction and system customization.
- Strong knowledge of global PV regulations (FDA, EMA, MFDS, PMDA, etc.).
- Business-level proficiency in Japanese (JLPT N2+ highly preferred).
- Ability to join immediately or within a short notice period.
- Willingness to work onsite in Japan.
Nice to Have:
- Experience with Japan-specific case processing or local regulatory submission formats.
- Prior work in cross-cultural project teams in APAC or global safety environments.
Why You Should Apply:
- Global Exposure: Join a project with international impact and strategic importance.
- Language & Leadership Edge: Use your bilingual expertise to bridge technology and compliance.
- Impactful Work: Play a direct role in patient safety and regulatory excellence.
- Relocation Support: Exceptional candidates outside Japan with required skills and language proficiency are welcome to apply.
How to Apply:
If you have the Argus expertise, speak fluent Japanese, and are ready for your next big move—we want to hear from you!
