Description

You will act as the primary subject matter expert for Pharmacovigilance (PV) safety systems, leading deliverables and managing audits and inspections.

Responsibilities

• Lead the design and specification of safety database requirements as a PV Systems SME.
• Oversee vendor and client report development, including Compliance, Aggregate, Signal Detection, Data Mining, and KPIs.
• Review and provide feedback on tenant configuration, business configurations, code list changes, and user permissions.
• Validate work instructions for database maintenance, upgrades, MedDRA/WHO Drug versioning, and ESG setup.
• Manage multiple global stakeholders and participate in system implementation and configuration.

Required Skills

• 9-19 years of experience in Pharmacovigilance systems and implementation.
• Fluent Japanese (speaking, reading, and writing) with ability to translate between English and Japanese.
• Deep functional knowledge of PV Safety Systems such as Oracle Argus Safety or Lifesphere MultiVigilance.
• Experience in installing, configuring, and validating PV safety databases.
• Strong understanding of pharmacovigilance principles and practices.
• Proven ability to handle data mining and system design specifications.
• Bachelor's degree.

Preferred Skills

• JLPT N1 or N2 certification.

Key Skills

Education

Bachelor