About this role
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.