Patient Safety Project Lead / ペイシェントセーフティ プロジェクトリード（東京・大阪）
Parexel · Osaka
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Patient Safety Project Lead（PSPL）は、ファーマコビジランス（PV）および安全性業務に関するプロジェクト全体をリードし、クライアントとの関係構築、プロジェクト管理、品質管理、リソース最適化、財務管理を担う重要なポジションです。グローバルチームやクライアントと連携しながら、安全性プロジェクトを円滑に推進し、高品質なサービス提供を実現いただきます。
【業務内容】
クライアントマネジメント
- クライアントとの信頼関係構築および維持
- 安全性サービスに関する窓口対応
- プロジェクトパフォーマンスのモニタリングおよび改善提案
- 提案書作成やビジネス開発活動への参画
- クライアント会議やガバナンスミーティングへの参加
プロジェクトマネジメント
- プロジェクト計画の策定および進捗管理
- スケジュール、成果物、予算の管理
- リソース計画およびフォーキャスト作成
- スコープ変更管理
- 財務管理および収益予測
- 社内外ステークホルダーとの調整
クロスファンクショナルな連携
- Clinical Operations、Data Management、Medical Servicesなど各部門との協業
- ベンダーおよび規制当局対応
- グローバルチームとの連携
クオリティ・コンプライアンス管理
- 安全性関連成果物の品質管理
- ICH、GCP、FDA、EMAおよび各国規制要件への準拠
- ファーマコビジランスシステムの適切な運用
- 監査対応および継続的改善活動
必須要件
- ファーマコビジランスまたは安全性業務における豊富な実務経験
- 製薬企業、CRO、医療業界等での5年以上の業務経験
- プロジェクトマネジメント経験
- 英語による読み書き、プレゼンテーション能力
- クライアント対応経験
- 複数案件を管理できる優れた調整力・優先順位付け能力
歓迎要件
- プロジェクトリードまたはチームリード経験
- 安全性データベースやPVシステムに関する知識
- 予算管理・収益管理経験
求める人物像
- リーダーシップを発揮し、チームを成功に導ける方
- クライアントとの長期的な関係構築ができる方
- 主体的に課題解決へ取り組める方
- グローバル環境での業務に興味のある方
- 安全性領域の専門性をさらに高めたい方
Client Liaison/Service
- Supports establishment of collaborative client relationships that foster trust, efficiency, and professional engagement
- Implement data-driven performance metrics and key performance indicators to quantitatively measure success and drive continuous improvement for assigned projects
- Proactively address client concerns, providing timely solutions and feedback to safety services management
- Contribute knowledge to proposal development for standalone through end-to-end safety services
- Assess service scope requirements, providing detailed task descriptions and resource estimations
- Represent Parexel patient safety services at business development meetings, bid defenses, and client governance forums as needed
Project Management
- Develop and maintain comprehensive project plans with clear milestones, deliverables, and timelines
- Monitor task progression and overall program performance, implementing corrective actions as needed
- Facilitate transparent communication regarding project status to clients and internal stakeholders
- Conduct regular financial oversight, comparing actual versus planned budgets and optimizing resource utilization
- Provide forecasting to patient safety services management, proposing innovative solutions for timeline shifts and staffing requirements
- Ensure proper scope change management to maintain project profitability
- Oversee revenue recognition, forecasting activities, and contractual invoicing for small standalone projects, or supports these activities proactively for full-service projects
- Serve as primary point of contact for financial matters, coordinating with Project Analysts, related to patient safety services
- Represent patient safety services during external audits, addressing findings and implementing improvements
Cross-Functional Collaboration
- Coordinate seamlessly with internal teams (e.g., Business Operations, Clinical Operations, Data Management, Safety technology)
- Manage relationships with external patient safety stakeholders (clients, vendors, health authorities)
- Provide expert guidance on process-related issues in accordance with ICH, FDA, EMA, and other applicable guidelines
- Partner with Subject Matter Experts to enhance quality, efficiency, and project management methodologies
Quality & Compliance Leadership
- Ensure consistent delivery of high-quality deliverables that meet or exceed client expectations
- Stay current with industry advances, regulatory updates, and emerging trends in patient safety
- Apply in-depth knowledge of pharmacovigilance systems and regulatory requirements
- Maintain compliance with ICH, GCP, and relevant geographic regulations
General
- Foster a positive, results-oriented work environment that emphasizes partnership and teamwork
- Communicate openly, transparently, and objectively with team members
- Provide leadership and coverage during management absences
- May supervise direct reports and provide functional oversight across the SBU when required
Skills:
- Some leadership abilities with demonstrated success in building effective project teams
- Strong motivational skills with proven ability to delegate effectively and make quality decisions
- Proficient knowledge of pharmacovigilance technology and systems and safety database management
- Some experience in business operating procedures including contract management, revenue recognition, and project lifecycle management
- Effective budget planning and financial management experience
- Ability to prioritize effectively and manage multiple projects simultaneously
- Collaborative mindset with demonstrated success in matrix environments
- Proactive problem-solving approach with ability to create appropriate sense of urgency
- Strong understanding of clinical research processes and drug development lifecycle
- Robust written and verbal communication skills
Knowledge and Experience:
- Extensive drug safety knowledge with substantial experience in pharmacovigilance
- Minimum 5+ years working in drug development and/or healthcare environments
- Proven project management experience with demonstrated team leadership capabilities
- Strong command of written and spoken English; additional language proficiency as required
- Established track record of developing and maintaining client relationships
- Specialized experience in clinical adjudication and data monitoring committee processes, specifically for CAC and DMC projects management
- Proficiency with IDRA workflows, committee governance, and adjudication technology platforms, specifically for CAC and DMC projects management
- Comprehensive understanding of pharmacovigilance systems and regulatory requirements
Education:
- Degree in Pharmacy, Nursing, Life Science, or other health-related field, or relevant work experience in Pharmacovigilance.
- A certification in project management is an advantage.