[R&D] PMS Planning & Operations Lead（一般社員）

[DJ] PMS Planning & Operations Lead

Position Purpose:

• Develop and execute a strategy to maximize product value through effective post marketing activity management, ensuring regulatory compliance, Risk Management Plan (RMP), budget control, timeline adherence and quality assurance within Post Marketing Study(PMS), including Drug use-results survey, database research and other types of studies.
• Provide an efficient PMS study plan as a part of RMP, aligned with the Life Cycle Management (LCM) strategy.
• Oversee Contract Research Organizations (CRO) to ensure the performance and the quality standards.
• Lead and contribute to the improvement of the PMS environment in Japan and other countries through active engagement with industry stakeholders.
• Promote data sharing with other countries to enhance the value of PMS data, working closely with international colleagues.
• Drive organizational goal of the division and company.

Role and responsibilities:

• Responsible for developing a PMS strategy aligned with RMP to achieve the following objectives:
• Maximize the product value by generating safety data in Japanese from actual clinical setting. Ensure PMS strategy and plan is consistent with RMP strategy and agreements with regulatory authority (PMDA/MHLW) at the time of project approval.
• Conduct PMS activities and be accountable for the performance and outcomes:
• Deliver operational strategy for assigned programs. Ensure project deliverables meet Pfizer/industry-leading standards for quality, speed, and cost in Non-Interventional Studies (NIS). Ensure inspection readiness, including appropriate risk management and CAPA (Corrective and Preventive Actions). Manage external CROs to ensure reliable study execution and expand their scope of services.
• Collaborate with various stakeholders to maximize product value through post marketing activities:
• Work closely with PMS Operations, Data Management, and Programming teams to generate rapid, efficient, and high-quality data. Engage with industry organizations such as JPMA, PhRMA to improve PMS environment in Japan. Build strong relationship with external stakeholders including PMDA, key opinion leaders and academic societies.

Desired Skills and Experiences:

Behavioral Skills:

• Understanding of Pharmaceuticals and Medical Devices Law, GPSP/GVP/ GCP and SOPs, and applicable to clinical and post marketing areas
• Ability to manage multiple projects and cross-functional processes in a timely manner
• Demonstrated quick and effective decision-making skills
• Ability to manage budget as planned
• High level of accountability with confidence to take initiative and drive business forward

Experiences:

• A minimum of 5 years' experience in the Pharmaceutical Industry is required.
• Experience designing and/or overseeing in interventional/non-interventional studies is preferred. (more than 5 years' experience is ideal)

Education/Certification:

• BS / MS / PhD / MD / MPH or equivalent qualifications are desired

Language:

• Fluent in oral and written Japanese
• Sufficient level of verbal communication skills in English are required, including the ability to deliver presentation at meetings and engage in professional and technical discussion.
• TOEIC score 700 over or equivalent qualifications are preferable

Work Location Assignment: Hybrid