Post Marketing Surveillance (PMS) Sr Associate (Sr Associate Global Safety)

Job Summary

As part of the Japan Safety organization at Amgen KK., the Japan Safety PMS Sr associate is responsible for leading assigned PMS project(s) and executing operational activities for PMS under the guidance of PMS manager, PMS Sr. manager or PMS head in line with applicable corporate policies and procedures, as well as local regulations and practices, in collaboration with other local and global functions such as global and Japan EGT, 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. This role reports to the Japan Safety PMS Sr manager, PMS manager or PMS head.

Key Activities

Management and Leadership:

• Develop and maintain a budget and timeline for assigned PMS project(s). Technical Expertise in PMS:
• 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 under the guideline of PMS manager or PMS Head.
• Communicate key issues related to project management of assigned PMS activities to Project lead (PMS manager, PMS Sr manager or PMS head, 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:

• Contribute to the creation and maintenance of business procedure documents (e.g., SOPs, GDEs) of PMS activities.
• Contribute to 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.
• Executing data management plans and statistical analysis plans and reporting the results of both activities.
• Selecting, overseeing, and evaluating external service providers.
• Ensuring 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.

Training and other cross-functional responsibilities:

• 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.

Knowledge and Skills

(Basic)

• Working knowledge of GPSP, GVP, and GCP (as applicable to post-marketing clinical studies)
• Strong communication skills (orally and in writing)
• Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project

(Preferred)

• 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 data management and statistical analysis
• Ability to develop the business procedures for operational aspects of PMS activities (e.g. contract and payment, data management, statistical analysis, self-inspection, training, documents archiving) for PMS and execute those.
• English language proficiency (business discussions, reading, and writing)
• Ability to write and edit business process documents (e.g. SOPs, GDEs)
• Working in matrix environment, communicating cross-functionally and cross-regionally
• Working knowledge of electronic data capture (EDC) and PMS tracking system