Safety Project Director / セーフティプロジェクトダイレクター

■職務内容

薬事法や安全性に関する規制及び社内の標準操作手順(SOP)を遵守し、市販後、治験中・承認申請中の治験薬に係る安全性情報について評価し、規制当局または、クライアントの安全性管理部門へ定められた期間内に適切に報告する責務を負う。

具体的には

・クライアントの業務依頼から始まる要求確認を含めたクライアントとの折衝業務

・リソース計画、ワークロードの管理

・マネジメントメンバーと話し合い、決定した事項やPolicyをメンバーにカスケード。

・コンプライアンス、タイムライン、予算を遵守させ、プロジェクトの品質を維持向上させ、クライアントの期待を満たす。

・内部、外部の監査をサポートし、適切な是正措置をとれるようにする。

・スタッフへの指導、育成、マネジメント

• Serves as technical expert of PV for internal and external stakeholders for multiple projects/functions

• Managing overview of the entire project and client liaison for all processes

• Validate quality and training compliance compiled by the project managers and Team Leads

• Ensure appropriate billable time for line reports.

• Undertake the full range of duties relevant to performance management of line reports:

• Build and maintain collaborative client relationships, to cultivate efficient, productive, and professional working relationships that promote satisfaction and confidence.

• Implement quantitative measures of performance (key performance indicators provided by the client or developed internally) into feedback, metrics, and continuous improvement activities to optimize performance in a data-driven manner.

• Respond appropriately to incidents of dissatisfaction and provide feedback to safety services management.

• In the proposal generation process, provide strategic and project planning intelligence to safety services management for standalone through end-to-end safety services

• Provide an assessment of scope of services for clients with respect to safety services tasks, including a description of the services to be performed and estimated hours for each task. Liaise with the proposal team and/or client to ensure that the proposal covers all services required.

• If called upon, attend business development and bid defense/proposal meetings to prepare and present to clients.

• Build external and internal partnerships by actively cultivating a broad range of networked partners that enable more effective collaboration with other business elements to fully leverage the Parexel brand capabilities.

• Participate in governance meetings (as applicable).

• Set clear objectives for assigned safety services team members/line reports and continuously monitor performance against these objectives.

• Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks.

Qualifications■必要業務経験

・安全性関連業務を5年以上経験された方

・チームをリードした経験

・英語力を有する方

■ 歓迎

・クライアントフェーシングの経験があれば、尚可。

■ 求める人物像

・新しいことに意欲的に取り組んでいける方

・積極的に問題解決に取り組める方

・コミュニケーション力の高い方

・チームワークの重要性を理解し、良好な関係を築ける方

・期限を遵守できる方

• Excellent interpersonal, negotiation, verbal and written communication skills.

• A professional and flexible attitude with respect to work assignments and new learning.

• Motivation to work independently and consistently in a fast-paced, rapidly changing environment.

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention

to detail, e.g., organizational skills.

• Competent working in a matrix environment and values the importance of teamwork. Possesses

team leadership skills, cross-cultural sensitivity and can influence without authority.

• Exhibits logical thinking and sound judgement. Escalates issues to departmental management

as appropriate. Presents solutions and follows through to ensure problems have been

satisfactorily resolved.

• As client liaison, demonstrates a client-focused approach to work and establishes a connection

with the client, to gain repeat business and/or to widen existing scope and services.

• Ability to gain trust and confidence within the company.

• Ability to act with confidence during demanding situations in the face of opposition, challenge, or

anxiety.

• Provides departmental expertise and perspectives to promote prospective business opportunities; provides Parexel colleagues with pertinent information to formalize a sound business strategy.

• Relevant significant experience is desirable.

• Demonstrated understanding of pharmacovigilance and clinical research, the drug development process, and applicable regulatory guidelines and regulations.

• Broad experience in management of complex pharmacovigilance processes.

• Demonstrate understanding of people management: previous line management experience, or

equivalent, preferably in a billable service industry.

• Project management experience (e.g., planning and monitoring).

• Business awareness/business development experience.

• Knowledge of resource management and productivity metric management.

• Advanced word processing skills, including Microsoft (MS) Office (expertise in Word and

competency in Excel); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (e.g., MS Access).

• Degree in life Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.).

• A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.