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）

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.