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About the Role

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.

Responsibilities

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.
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.

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.
5+ years of experience supporting Pharmacovigilance, Drug Safety, or Safety Technology systems.
Demonstrated experience supporting complex, cross-functional technology initiatives in a regulated environment.
Mandatory experience with PMDA pharmacovigilance requirements, Japan-specific safety reporting processes, and E2B reporting standards.
Strong understanding of PV business processes such as case processing, intake, triage, reporting, reconciliation, literature management, submissions, and compliance operations.
Good understanding of GxP and Computer System Validation concepts in regulated technology environments.
Hands-on experience with pharmacovigilance safety systems such as Oracle Argus Safety, ArisGlobal LifeSphere MultiVigilance, or equivalent PV technology platforms.
Experience with safety system implementation, enhancement, upgrade, migration, integration, reporting, or production support initiatives.
Strong Oracle SQL skills for data analysis, troubleshooting, validation support, and requirements clarification.
Understanding of SDLC methodologies including Agile, Waterfall, or hybrid delivery models.
Working knowledge of FDA, EMA, ICH, and other global pharmacovigilance regulations.
Experience in pharmaceutical, biotechnology, CRO, or life sciences technology environments.
Experience with Oracle Argus Insight, reporting tools, data warehouses, analytics platforms, or PV integrations.
Knowledge of GAMP 5 and risk-based validation approaches.
Professional certification such as CBAP, PMI-PBA, SAFe, Agile, or equivalent is a plus.
Experience working with global teams, vendors, offshore delivery teams, and managed services partners.

Skills

Pharmacovigilance operations
Safety systems
Japan PV requirements
Compliance expectations
Business Analysis Leadership
Requirements definition
Documentation
Impact assessment
Solution alignment
Regulatory & Validation Mindset
GxP
CSV
Traceability
Audit readiness
Validated system controls
Technical Fluency
Safety platforms
SQL
Integrations
Data flows
SDLC delivery teams
Stakeholder Management
Mentorship
Oracle SQL

Location

Tokyo (Shinagawa) Office

Work Type

Hybrid Workstyle
Permanent Staff Role
Flexible Working
Work From Home (Hybrid)

Experience Level

Senior
8+ years of experience in Business Analysis, Systems Analysis, Product Analysis, or Technology Delivery
5+ years of experience supporting Pharmacovigilance, Drug Safety, or Safety Technology systems

Education Level

Bachelor’s degree in Life Sciences, Pharmacy, Computer Science, Information Systems, Business, or a related discipline.

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
We aim to realize a society where everyone can live healthier and more fulfilling lives by supporting those working to advance healthcare with IQVIA's unique innovative solutions, as a pioneering company in human data science.
Based on the world's largest healthcare data, we aim to advance healthcare to a better future for the benefit of all people, including patients, by responding to unmet medical needs, developing and commercializing new drugs and medical devices, addressing increasingly strict regulations and compliance, and supporting the promotion of sustainable healthcare systems from the perspective of integrating people, data, and science.
As the Japanese subsidiary of IQVIA, which operates in over 100 countries and regions worldwide with approximately 90,000 employees, approximately 6,000 employees at IQVIA Japan are working together every day towards this mission.

Equal Opportunity

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.