Amgen Global Safety Manager in Tokyo, Japan
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), as appropriate.
Align local PMS activities with global strategy by collaborating with applicable Amgen stakeholders (e.g., Global Safety Officer, Centre for Observational Research representative).
Compliance, Quality, and Regulatory
Responsible for ensuring compliance with internal business procedures and applicable local regulatory requirements (e.g., GPSP, and Good Vigilance Practice [GVP]), including compliance related to interactions with medical institutions and healthcare professionals.
Develop, maintain, and deliver on a training plan and its execution for personnel involved with assigned PMS activities.
Contribute to inspection readiness efforts and other inspection/audit-related activities of assigned PMS activities.
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.
Monitoring progress of PMS activities, in collaboration with internal functions and external parties (including business partners, when applicable).
Preparing reports for regulatory submission in accordance with applicable requirements, including those in support of re-examination dossiers.
Building and maintaining good working relationship with external subject matter experts in collaboration with other relevant functions and business partners, when applicable.
Collaborating to generate and provide data (e.g., publication) as a proper drug use information with internal functions (e.g., medical affairs).
Archiving necessary documents for PMS activities appropriately.
Collaborating to ensure self-inspection.
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 partners
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
Education and Experience (Preferred)
Master's degree & 5 years of directly related experienceORBachelor's degree & 7 years of directly related experience
Work experience as a project leader in the execution of the activities for one or more PMS (from the planning to the completion of re-examination activities).
Completion of re-examination activities for approved drugs, including the preparation of dossiers for regulatory submission and handling of regulatory inquiries and inspections.