メディカル・バイオ - 安全性情報（臨床開発・製販後GVP）

•Line manager Patient Solution Service staff include performance reviews, human resource issues, and assist Senior PSS Management in assigning resources to projects.
•Manage the overall PSS operations associated with products including the entire adverse events process; which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports) for specified projects.
•Manage and process expedited adverse events and expedited safety reports to the required standard and ensured submission of them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business.
•Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
•Individuals will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

Qualifications (Minimum Required):
•For PharmD, a one-year residency of fellowship can be considered relevant experience.
•Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
•Fluency in Japanese and English speaking, writing and reading required
Experience (Minimum Required):
•Good verbal, written and presentation skills.
•Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level.
•Work collaboratively with PSS Management’s team.
•Strong Leadership capabilities.
•Excellent Communication.
•Overall departmental resource Management.
•Client Service Focus.
•Ability to multitask and prioritize.
•High degree of accuracy with attention to detail.
•Ensure client and global regulatory compliance.
•Will present and share useful business information across departments and functions.
•Anticipate/identify problems and takes appropriate action to correct.
•Knowledge of medical and drug terminology.
•Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
•Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
•Financially intuitive.
•Knowledge of ICH guidelines.
•Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
•Deep understanding of Japanese GCP and GVP regulations
•Experience in vendor management & oversight
•Experience with local safety database configuration & migration
•Experience in proposal development & budgeting, strategic client engagement, market intelligence & positioning

Preferred Qualifications Include:
•Non-degree + 10 yrs. safety experience.
•Associate degree + 8-9 yrs. safety experience.
•Associate degree RN + 7-8 yrs. safety experience.
•BS/BA + 6-7 yrs. relevant experience.
•MS/MA + 5-6 yrs. relevant experience** (4-5 yrs. safety experience*).
•PhD / PharmD + 3-4 yrs. relevant experience** (2-3 yrs. safety experience*) + 1-2 years of team leadership experience
•For PharmD, a one-year residency of fellowship can be considered relevant experience.
•Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
•Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
•Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
•Team leadership experience includes experience bearing overall responsibility for work products generated for customers by supporting team members operating in matrix environment, assigning, and coordinating work executed by a team of supporting staff, organizing efforts of more than one individual to achieve common team objectives.
•At least 3-4 years line management and/or project management experience preferred.
•Knowledge of Medical Device Reporting desirable.
•Knowledge of aggregate reporting desirable.
•Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.

■職種未経験者：不可