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

Reposted 8 Hours Ago
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Tokyo
Hybrid
Senior level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Develop and execute a PMS strategy aligned with RMP to maximize product value, ensuring quality control and regulatory compliance while managing multiple projects.
Summary Generated by Built In
[DJ] PMS Planning & Operations Lead(一般社員)
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
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs

Top Skills

Database Research
Drug Use-Results Survey
Medical Devices
Non-Interventional Studies (Nis)
Pharmaceuticals
Risk Management Plan (Rmp)

What the Team is Saying

Daniel
Anna
Esteban
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The Company
HQ: New York, NY
121,990 Employees
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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Pfizer Offices

Hybrid Workspace

Employees engage in a combination of remote and on-site work.

Typical time on-site: Not Specified
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HQHudson Yards
Provincia de Buenos Aires
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Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
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Andover, MA
Andover, MA
Andover, MA
Andover, MA
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