Senior Business Analyst (Pharmacovigilance Technology)

Location: Tokyo (Shinagawa) office with a hybrid workstyle

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead discovery, analysis, prioritization, and documentation of complex business requirements across pharmacovigilance, drug safety, and regulatory functions.
• Define system scope, business rules, functional requirements, user stories, process flows, and specifications for compliant PV technology solutions.
• Support safety system implementations, upgrades, integrations, migrations, reporting, enhancements, and production support throughout the SDLC.
• Use Oracle SQL for data analysis, issue investigation, report validation, and requirements clarification.
• Support computer system validation, risk assessments, traceability, test documentation review, audit readiness, and maintenance of the validated system state.
• Facilitate stakeholder workshops and solution reviews while mentoring less-experienced Business Systems Analysts.

Requirements

• Bachelor’s degree in life sciences, pharmacy, computer science, information systems, business, or a related discipline.
• 8+ years of experience in business analysis, systems analysis, product analysis, or technology delivery, including 5+ years supporting pharmacovigilance, drug safety, or safety technology systems.
• Mandatory experience with PMDA pharmacovigilance requirements, Japan-specific safety reporting processes, and E2B reporting standards.
• Strong understanding of PV processes including case processing, intake, triage, reporting, reconciliation, literature management, submissions, and compliance operations.
• Hands-on experience with Oracle Argus Safety, ArisGlobal LifeSphere MultiVigilance, or equivalent PV platforms, plus strong Oracle SQL skills.
• Understanding of GxP, computer system validation, SDLC methodologies, and regulated technology delivery.

Nice to have

• Knowledge of FDA, EMA, ICH, GAMP 5, and risk-based validation approaches.
• Experience with Oracle Argus Insight, reporting tools, data warehouses, analytics platforms, or PV integrations.
• Experience in pharmaceutical, biotechnology, CRO, or life sciences technology environments.
• Professional certification such as CBAP, PMI-PBA, SAFe, Agile, or equivalent.
• Experience working with global teams, vendors, offshore delivery teams, and managed services partners.

Culture & Benefits

• Permanent staff position.
• Hybrid work with work-from-home availability.
• Flexible working arrangements.
• Working hours are 9:00–17:00.
• Six-month probation period.

Hiring process

• CV screening followed by three interviews.