転職AI
保存・履歴

保存と履歴は、この端末のブラウザにだけ残ります。会員登録すると、スマホとPCで同じ一覧を見られ、条件に合う新着求人もメールで届きます。

ログインマイページ
求人へ
職種・勤務地・キーワードで探す
条件を変える

こだわり条件

こだわり条件
条件をクリア
東京都のシステムエンジニア（SE・SIer）の求人1,385件

Senior Business Analyst (Pharmacovigilance Technology)

IQVIAソリューションズ ジャパン合同会社

この会社の求人 29件

掲載中・1日前に確認

給与
記載なし
勤務地
東京都
休日
記載なし
雇用形態
正社員

どんな仕事かAIによる生成

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.

応募資格・募集要項・仕事内容を見る

この求人に応募

給与記載なし

募集元で応募するIQVIAソリューションズ ジャパン合同会社の採用ページへ
相談する共有準備中

応募は募集元の採用ページで受け付けています。当サイトに応募フォームはありません。

応募資格

必須

  • Education & Experience

    • 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 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.

歓迎

  • 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.

募集要項最終確認 11/12

職種
システムエンジニア（SE・SIer）
雇用形態
Permanent Staff RoleProbation Period: 6 months
役職
This role is positioned as a senior individual contributor within PV Technology.
給与
記載なし
勤務地
Tokyo (Shinagawa) Office
働き方
Tokyo (Shinagawa) Office (Hybrid Workstyle)Work From Home：Yes (Hybrid)
勤務時間
Working Hours：9:00〜17:00Flexible Working：Yes
経験年数
5年以上
学歴
大学卒業以上
選考の流れ
CV Screening~3 Interviews
掲載日
2026/09/24 02:51（50日前）
最終確認
2026/11/12 22:07（1日前）

仕事内容

Job Overview

  • 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.

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.

募集内容

  • 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.

この求人は、IQVIAソリューションズ ジャパン合同会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト

同じ会社の求人29件

IQVIAソリューションズ ジャパン合同会社の求人をすべて見る（29件）

職種と勤務地が似ている求人東京都のシステムエンジニア（SE・SIer） 1,385件

東京都のシステムエンジニア（SE・SIer）の求人をすべて見る（1,385件）

募集元の採用ページから応募できます

応募はIQVIAソリューションズ ジャパン合同会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。

募集元の採用ページを開く

この求人と近い条件で探す数字はリンク先ページの掲載件数

応募資格の語から探す

この職種で探す

この勤務地で探す

働き方・年収で探す

この職種を募集する企業

募集元で応募する採用ページへ
AI相談