|部署・役職名||【外資CRO/新規案件ポジション】Manager, Safety ＆ Pharmacovigilance|
1. Quality Manager: PVプロジェクトにおける業務改善（根本原因分析、CAPA管理、KPI管理など）
2. Work Flow Manager: PVプロジェクトにおける症例期限管理
Manages Safety team members responsible for all Safety services while adhering to all data protection
guidelines, Health Insurance Portability and Accountability Act （HIPAA）, Good Clinical Practices （GCPs）,
regulatory guidelines, Good Pharmacovigilance Practices （GVP） and study procedures. Participates in
process development, budget reviews, and project management. Ensures consistency and
communication between the Safety team members and management.
Line management responsibilities including transfers, hiring, utilization, terminations, training,
professional development, performance appraisals, time sheet approval, and employee counseling.
Advises staff on administrative policies and procedures, technical problems, and prioritization.
Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on
organizational goals and company objectives.
Monitors quality of work and efficiency of team members with contracted scope of work and Safety
Management Plan. Discusses below－target project goals with senior safety management.
Manages projects where Safety and Pharmacovigilance are the primary services.
o Reviews study budgets and expenses; ensures all study related contractual and budgeting
issues are upheld and performed.
o Works with Finance to ensure appropriate customer invoicing, where required.
o Approves project time cards and invoicing.
o Provides sponsors with scheduled project updates and reports.
o Coordinate with other internal departments and Safety functional areas to ensure timely
review and submission of reports and documents relating to safety reporting as well as
resolution of issues.
Participates in the management of the Safety and Pharmacovigilance department with the following
o Assists in the development, review, and approval of departmental Standard Operating
o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety
o Evaluates processes for potential improvement in efficiency and effectiveness and
recommends changes. Participates in process development and improvement of
o Works with Business Development to actively solicit new business, as needed.
o Represents Safety and Pharmacovigilance or ensure Safety representation at project team
meetings and client meetings.
Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately
reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings.
Reviews clinical safety sections of study protocols and Case Report Forms （CRFs） to make sure
information is consistent with the Serious Adverse Event form. Approves budget pro jections for the
Maintains understanding and ensures compliance of SOPs, Work Instructions （WIs）, global
drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug
Responsible for the identification, preparation, and delivery of any necessary training to Safety team
members and other departments or groups. Mentor Safety team members
Managing resourcing's needs/issues and escalating to senior management as necessary.
Participates in audits/inspections and ensures inspection readiness. Participates in quality
investigations and implementation of corrective and preventive actions.
Performs other work related duties as assigned.
Minimal travel may be required.
【必須（MUST）】QUALIFICATION REQUIREMENTS （please indicate if ‘preferred’）
BA/BS in the biological sciences or related disciplines in the natural science/health care field or
nursing degree or equivalent combination of education and experience
Progressive responsibility with demonstrated leadership skills and project management
Clinical Research Organization （CRO） experience with therapeutic specialties preferred
Working knowledge of financial budgets and various financial analysis tools preferred
Proficiency in Microsoft Office Suite （Word, Excel, and PowerPoint）, Visio, email （Outlook）,
TeamShare （or other management/shared content/workspace）, and internet
Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills
Ability to establish effective relationships with clients as well as team members
Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix
Ability to make effective decisions and manage multiple priorities while delivering high quality work in
a dynamic environment