Senior Business Analyst (Pharmacovigilance Technology)

The Senior Business Analyst serves as a key bridge between Pharmacovigilance, Safety Operations, Quality, Compliance, and Technology teams to support the delivery and enhancement of global safety systems and business processes.

This role leads complex business analysis activities across PV technology initiatives, including regulatory compliance, system implementations, system enhancements, integrations, reporting, validation support, and continuous improvement programs.

The Senior Business Analyst translates business needs into clear, scalable, and compliant technology requirements, while providing subject matter expertise on PV systems and Japan-specific regulatory expectations.

The role also provides guidance to less-experienced Business Analysts and collaborates closely with cross-functional stakeholders, technical teams, vendors, and validation partners.

Lead discovery, analysis, and documentation of complex business requirements across Pharmacovigilance, Drug Safety, and Regulatory functions.

Formulate and define systems scope, objectives, business rules, functional requirements, user stories, process flows, and system specifications based on user needs and applicable business requirements.

Collaborate with business stakeholders, quality teams, and technology teams to analyze business requirements, support solution design discussions, and ensure successful implementation of compliant and scalable PV technology solutions.

Analyze business and user needs and translate them into practical system requirement specifications that can be used by development, configuration, testing, validation, and support teams.

Evaluate existing procedures, system behavior, data flows, and operational constraints to solve complex business and technology problems.

Support requirements prioritization, impact assessment, release planning, and implementation readiness for PV technology initiatives.

Provide expert business and systems analysis support for pharmacovigilance safety applications and related ecosystem integrations.

Work at a senior technical level across multiple phases of systems analysis while considering business implications of technology decisions in the current and future PV environment.

Support implementation, upgrade, integration, migration, reporting, and enhancement initiatives for safety platforms.

Use Oracle SQL capabilities to support data analysis, issue investigation, report validation, and requirements clarification.

Partner with development, testing, validation, and production support teams throughout the SDLC.

Ensure solutions comply with applicable GxP requirements and PMDA pharmacovigilance regulations, including Japan-specific safety reporting requirements and E2B standards.

Experience supporting FDA, EMA, ICH, and other global pharmacovigilance regulations is highly desirable.

Support Computer System Validation activities including risk assessments, validation planning, requirements traceability, test documentation review, and audit readiness.

Partner with Quality and Compliance teams to help maintain validated system state and support regulatory inspections or internal audits.

Serve as a trusted liaison between business stakeholders, technology teams, vendors, implementation partners, Quality, and Compliance.

Facilitate requirements workshops, solution reviews, walkthroughs, issue triage sessions, and stakeholder alignment discussions.

Provide guidance, review, and mentoring to less-experienced Business Systems Analysts.

Contribute to business analysis standards, documentation quality, re-usable templates, and consistent delivery practices within the PV Technology department.

Communicate complex business, regulatory, and technical topics clearly to both technical and non-technical audiences.

Strong understanding of pharmacovigilance operations, safety systems, Japan PV requirements, and compliance expectations.

Ability to lead requirements definition, documentation, impact assessment, and solution alignment for complex initiatives.

Practical understanding of GxP, CSV, traceability, audit readiness, and validated system controls.

Comfortable working with safety platforms, SQL, integrations, data flows, and SDLC delivery teams.

Able to communicate clearly with business, quality, compliance, vendor, and technical stakeholders.

Guides junior analysts and contributes to consistent BA standards and delivery practices.

The emphasis is on leading complex business analysis work, supporting regulated PV technology delivery, applying PMDA and GxP compliance knowledge, influencing cross-functional solution decisions, and mentoring less-experienced analysts.