私たちIQVIAはヒューマンデータサイエンスの先駆的な企業として医療ヘルスケアの前進に取り組む皆様をIQVIAならではの革新的なソリューションによってご支援することで誰もがより健康に自分らしく生きられる社会の実現を目指しています
世界最大規模を誇る医療ヘルスケア関連データを基盤に人データサイエンスを融合させた見地から未だ満たされない治療ニーズに応える新たな医薬品や医療機器の開発と市販化厳格化する規制やコンプライアンスへの対応持続可能な医療システム推進の支援など患者さんをはじめとするすべての人々のためにより良い未来へと医療ヘルスケアを前進させていく力となることが私たちの使命です
世界100以上の国と地域で約9万人が活動するIQVIAの日本法人としてIQVIAジャパンでは約6000人が一丸となりこの使命に向かって日々力を尽くしています
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.
Business Analysis & Solution Delivery
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.
PV Systems & Technical Expertise
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.
Compliance & Validation
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.
Stakeholder Management & Leadership
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.
Education & Experience
Bachelors 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 Domain & Regulatory Experience
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.
Safety Systems & Technical Skills
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.
PV Domain Expertise
Strong understanding of pharmacovigilance operations safety systems Japan PV requirements and compliance expectations.
Business Analysis Leadership
Ability to lead requirements definition documentation impact assessment and solution alignment for complex initiatives.
Regulatory & Validation Mindset
Practical understanding of GxP CSV traceability audit readiness and validated system controls.
Technical Fluency
Comfortable working with safety platforms SQL integrations data flows and SDLC delivery teams.
Stakeholder Management
Able to communicate clearly with business quality compliance vendor and technical stakeholders.
Mentorship
Guides junior analysts and contributes to consistent BA standards and delivery practices.
This role is positioned as a senior individual contributor within PV Technology. 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.
Tokyo (Shinagawa) Office (Hybrid Workstyle)
Permanent Staff Role
Working Hours9:0017:00
Flexible WorkingYes
Work From HomeYes (Hybrid)
Probation Period: 6 months
CV Screening3 Interviews
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. Learn more at
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.
Required Experience:
Senior IC
Employment Type : Full-Time
Experience: years
Vacancy: 1
Senior Business Analyst (Pharmacovigilance Technology) • Tokyo, Tokyo, Japan
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