Amgen PMS Operations Mgr in Tokyo, Japan
Facilitate patient access to Amgen products in Japan through the following:
Compliance with applicable local regulations
Development and maintenance of local business processes in pharmacovigilance (PV) and PMS, integrated in relevant Amgen processes
Development and execution of Japan risk management plan (J-RMP)
Assessment of safety data in Japan
Provision of safety expertise
Leading and collaborating on PMS activities
Interface with regulatory agencies and industry organization
Alignment with key cross-functional partners and business partners
Continuous improvement of business processes
Contribute to the creation and maintenance of business procedure documents (e.g., SOPs, work instructions) related to the operational aspects of PMS activities.
Develop and maintain the infrastructure and business processes in support of PMS activities by:
Developing standard templates for protocols and associated forms (e.g., questionnaires), data management plan, and statistical analysis plan for PMS activities (e.g., studies and surveys) in alignment with Japanese conventions (e.g., Good Postmarketing Study Practice [GPSP]).
Aligning the operating processes and procedures in the local PMS activities with global processes and procedures by collaborating with applicable Amgen functional stakeholders (e.g., Global Patient Safety, Center for Observational Research).
Executing data management and statistical analysis, and reporting the results of both activities, in collaboration with PMS Project Leads.
Selecting and overseeing external service providers, and evaluate them periodically.
Ensuring timely handling of contracts and payments.
Monitoring progress of PMS activities, in collaboration with PMS Project Lead, 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.
Archiving necessary documents for PMS activities appropriately.
Communicate key issues related to the operations of the PMS activities to PMS Lead, PMS Operations Team Managers, PMS Project Leads, concerned functions, and product teams (local, regional, or global), as appropriate.
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 related to the operations for personnel involved with PMS activities.
Contribute to inspection readiness efforts and other inspection/audit-related activities regarding the operations of PMS activities.
Contribute to develop and maintain a budget for the operations of PMS activities.
Working knowledge of data management and statistical analysis, as applied to PMS.
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.
Ability to write and edit business process documents (e.g. SOPs, work instructions)
Working knowledge of GPSP, GVP, and GCP (as applicable to post-marketing clinical studies)
Strong communication skills (orally and in writing)
Project management skills
Skills to manage cross-functional relations, including interactions with external service providers and business partners
Working in matrix environment, communicating cross-functionally and cross-regionally
Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project
Working knowledge of electronic data capture (EDC) and PMS tracking system, and computer system validation.
Ability to prepare PMS protocols and associated documents (e.g., survey questionnaires)
Proficient in English language (business discussions, reading, and writing)
Education and Experience (Preferred)
Master's degree & 5 years of directly related experienceORBachelor's degree & 7 years of directly related experience
5+ years of work experience in the execution of data management with using EDC in PMS activities or in clinical development.
Work experience in the execution of statistical analysis in PMS activities or in clinical development.
Completion of re-examination activities for approved drugs, including the preparation of dossiers for regulatory submission and handling of regulatory inquiries and inspections.