ビジネスSME ファーマコビジランス/ Business SME – Pharmacovigilance (PV)

A technology services company is looking for a Business SME – Pharmacovigilance (PV) professional. The selected candidate will analyse business processes, gather requirements, design functional solutions, manage Argus Safety activities, and support regulatory case processing and client delivery.

Responsibilities:

• Analyse client business processes and requirements and validate feasibility against Argus Safety and Argus J capabilities
• Gather requirements, design functional solutions, and support development and testing teams on enhancements
• Create and maintain configuration baseline documentation and define technical architecture and implementation methodology for Argus Insight and Cognos reporting tools
• Conduct impact analysis for enhancements and change requests before implementation to protect existing configurations
• Own Issue, Problem, and Change Management for the Argus Safety system within a GxP-validated environment
• Process safety information and perform initial ICSR triage in accordance with regulatory standards, PMDA requirements, guidelines, SOPs, and project requirements
• Assess cases for completeness, accuracy, and regulatory reportability
• Serve as a key client contact by addressing queries and providing updates on case processing activities
• Coordinate workflows across onsite and offshore teams, process owners, and stakeholders across multiple projects
• Support fit-gap analysis, stakeholder workshops, and UAT from a business perspective
• Conduct end-user training and knowledge transition in Japanese and English

Requirements:

• 10-15 years of experience in Argus Safety configuration and business analysis
• 10-15 years of experience in the Life Sciences domain, particularly Clinical Development or Pharmacovigilance and Argus Safety business analysis
• Strong expertise in Argus Safety and Argus J, particularly E2B functionality
• Hands-on experience in requirements gathering, functional analysis, and system design
• Experience conducting impact analysis for enhancements and change requests without disrupting existing configuration
• Experience in Issue, Problem, and Change Management for Argus Safety in a GxP environment
• Working knowledge of Japan PMDA regulations, including NULL report validation and analysis
• Experience working in onsite-offshore delivery models with daily coordination
• Familiarity with Argus Insight and Cognos reporting
• Possess a valid Japanese work authorisation required for non-Japanese nationals, including national, permanent resident, or work visa status
• Proficient in Japanese (JLPT N1 for non-residents); fluent level English for Japanese nationals or residents

Preferred requirements:

• Exposure to ICSR case-processing workflows including intake, triage, and coding
• Experience with a CRO, pharmaceutical company, or Pharmacovigilance consulting firm in the Japan market
• Familiarity with Oracle Cloud implementations and SQL or database structures for troubleshooting

About the Company:

A technology company providing digital engineering and software solutions to help organisations modernise their technology environments. Its services cover areas such as cloud, data, artificial intelligence, application development and digital transformation, supporting businesses in improving efficiency and developing innovative digital products.

Keywords:

ファーマコビジランス, 安全性情報, 薬事, ビジネスアナリシス, 要件定義, 機能設計, システム設計, 影響分析, 変更管理, 製薬業界, ライフサイエンス, 求人, 外資系

Job Ref: 0FFQDL