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(Associate) Director, Safety Operations / 安全性情報の(アソシエイト)ダイレクター

Parexel International Corporation

Tokyo, Tokyo, Japa

• 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.

• Monitor progress of each individual project task and assess the overall program.

• Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget.

• Keep client and team informed of project status.

• Review actual versus planned project budget for entire safety services

of projects for the respective client(s). Monitor resource utilization on safety services projects and compare projections to resource available, as required.

• Provide project updates to safety services management and assess forecasting and resourcing. Propose creative solutions for shifting timelines and staffing requirements to safety services management.

• Contribute to process development/improvement

• Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects. Ensure appropriate changes in scope are escalated.

• Identify and resolve interdepartmental problems and issues in a team-oriented environment through cooperative initiatives with other Parexel operational and administrative department heads.

• Coordinate with other regional safety services management to oversee maintenance of process-related standard operating procedures (SOPs) and guidelines with continual evaluation of systems for improvement.

• Discuss improvement ideas with colleagues within and outside of safety services.

• Attend external audits as required; respond to audit reports and follow up on any issues highlighted.

• Maintain ultimate responsibility for safety services aspects of assigned projects, without supervision.

• Provide guidance for process related issues for example preparing of reports or case processing, as per the current ICH, FDA, EMA, and other applicable guidelines.

Qualifications• 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.

Job posted: 2021-11-20

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