安全性情報マネージャー(PMS)

Job Details

<Job Summary>
Japan Safety PMS Project Lead is responsible for leading assigned PMS project(s) in line with applicable corporate policies and procedures, as well as local regulations and practices, in collaboration with other functions in the local operating company, such as Safety (Pharmacovigilance), Sales & Marketing, Medical Affairs, Clinical Development, and Regulatory Affairs, external service providers (e.g., CROs), and business partner(s), when applicable, to meet business needs.

<Key Activities>
Management and Leadership:
・Develop and maintain a budget and timeline for assigned PMS project(s).
Technical Expertise in PMS:
・Lead or contribute to process improvement initiatives or implementation of
legislative changes in PMS area.
・Provide PMS and project management expertise for PMS discussions/meetings with local regulators and in local industry organizations.
・Communicate key issues related to project management of assigned PMS activities to PMS Lead or PMS Project Management Team Manager, concerned functions and product teams (local, regional, or global).
・Align local PMS activities with global strategy by collaborating with applicable
stakeholders.
Compliance, Quality, and Regulatory:
・Contribute to the creation and maintenance of business procedure documents (e.g., SOPs, work instructions) of PMS activities.
・Plan, execute, and evaluate PMS activities for assigned project(s) by: Developing protocols and associated forms (e.g., questionnaires) for PMS activities in alignment with the Japan risk management plan from scientific and clinical
aspects as well as points of the regulations.
・Contributing to the development, execution, and reporting on data management
plans and statistical analysis plans.
・Contributing to the selection and oversight of external service providers.
・Supporting the PMS Operations Team to ensure timely handling of contracts and
payments.
・Others

<応募要件>

・製造販売後データベース調査もしくはデータベースの臨床研究の経験をお持ちの
方を歓迎します。
・Skills to manage a project (e.g. issue management, budget and timeline
management) involving multiple internal and external functions for PMS activities,
which may involve external service providers and business partner.
・Ability to prepare PMS protocols and associated documents (e.g., survey
questionnaires)
・Working knowledge of GPSP, GVP, and GCP (as applicable to post-marketing
clinical studies)
・English language proficiency (business discussions, reading, and writing)
・Ability to write and edit business process documents (e.g. SOPs, work instructions)
・Strong communication skills (orally and in writing)
・Working in matrix environment, communicating cross-functionally and
cross-regionally
・Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project
・Working knowledge of data management and statistical analysis
・Working knowledge of electronic data capture (EDC) and PMS tracking system

※グローバルに展開するバイオ製薬企業で、オンコロジー領域においては業界トップレベルのメーカーです。

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company