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）

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.