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.
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
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
・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
・Working knowledge of GPSP, GVP, and GCP (as applicable to post-marketing
・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
・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