Senior Business Analyst - Pharmacovigilance Technology

About the role

The Senior Business Analyst acts as a bridge between Pharmacovigilance, Safety Operations, Quality, Compliance and Technology teams, supporting the delivery and improvement of global safety systems and business processes. The role leads complex business analysis across PV technology initiatives such as regulatory compliance, system implementations, enhancements, integrations, reporting, validation support and continuous improvement, and guides less-experienced Business Analysts. It is a senior individual contributor position based in the Tokyo (Shinagawa) office with a hybrid work style.

Key responsibilities

• Lead discovery, analysis and documentation of business requirements across Pharmacovigilance, Drug Safety and Regulatory functions, and turn them into system requirement specifications for development, testing, validation and support teams.
• Define systems scope, objectives, business rules, functional requirements, user stories, process flows and specifications, and support solution design and release planning.
• Support implementation, upgrade, integration, migration, reporting and enhancement of safety platforms, using Oracle SQL for data analysis, issue investigation and report validation.
• Ensure solutions comply with GxP and PMDA requirements, including Japan-specific safety reporting and E2B standards; support computer system validation, risk assessments, traceability and audit readiness.
• Run requirements workshops, solution reviews and issue triage, and mentor less-experienced Business Analysts.

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Computer Science, Information Systems, Business or a related field.
• 8+ years in Business Analysis, Systems Analysis, Product Analysis or Technology Delivery, with 5+ years supporting Pharmacovigilance, Drug Safety or Safety Technology systems.
• Mandatory experience with PMDA requirements, Japan-specific safety reporting and E2B standards, and PV processes such as case processing, intake, triage, reporting, reconciliation, literature management and submissions.
• Demonstrated experience in complex, cross-functional technology initiatives in a regulated environment.

Required skills

• Hands-on experience with PV safety systems such as Oracle Argus Safety, ArisGlobal LifeSphere MultiVigilance or equivalent.
• Strong Oracle SQL skills.
• Understanding of SDLC methods (Agile, Waterfall or hybrid).
• Preferred: knowledge of FDA, EMA, ICH regulations, GAMP 5, and certifications such as CBAP, PMI-PBA or SAFe.

What we offer

• Permanent staff role with working hours 9:00-17:00.
• Flexible working and work from home options.
• 6-month probation period.