Lead and execute strategies for Post Marketing Surveillance to ensure compliance, quality, and efficiency in product value maximization, engaging with stakeholders and overseeing CROs.
Position Purpose:
Role and responsibilities:
Maximize the value of the product by generating the safety data in Japanese in actual clinical setting. Ensure PMS strategy and the plan consistent with RMP strategy and regulatory authority (PMDA/MHLW) agreement by the project approval.
Responsible for delivery of Operational Strategy in assigned programs. Ensure projects deliverables align with Pfizer/industry leading standards on quality, speed, and cost for NIS. Ensure inspection readiness, including appropriate risk management and CAPA (corrective and preventive actions). Manage external CRO to ensure reliable study execution and increase their scope of services.
Work closely with PMS Operation, Data Management and Programming to generate rapid, efficient and high-quality data. Work with industry relations such as JPMA, PhRMA to improve PMS environment in Japan. Build good relationship with external stakeholders such as PMDA, key opinion leaders and academic society etc.
Desired Skills and Experiences:
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
#LI-PFE
- Develop and execute a strategy to maximize value of the products from the management of post marketing activities, by assuming responsibility for the regulatory compliance, Risk Management Plan (RMP), budget, timeline and quality in the Post Marketing Surveillance (PMS).
- Provide an efficient PMS study plan as a part of RMP in align with the Life Cycle Management (LCM) strategy.
- Oversee Contract Research Organizations (CRO) to ensure the performance and the quality they provide.
- Lead and contribute improvement of the PMS environment in Japan through industry relations.
- Drive organizational goal of the division and company.
Role and responsibilities:
- Responsible for developing a PMS strategy to align with RMP, to achieve the followings:
Maximize the value of the product by generating the safety data in Japanese in actual clinical setting. Ensure PMS strategy and the plan consistent with RMP strategy and regulatory authority (PMDA/MHLW) agreement by the project approval.
- Conduct PMS activities, and account for the performance and the results:
Responsible for delivery of Operational Strategy in assigned programs. Ensure projects deliverables align with Pfizer/industry leading standards on quality, speed, and cost for NIS. Ensure inspection readiness, including appropriate risk management and CAPA (corrective and preventive actions). Manage external CRO to ensure reliable study execution and increase their scope of services.
- Collaborate with various stakeholders to ensure maximizing value of the products from post marketing activities:
Work closely with PMS Operation, Data Management and Programming to generate rapid, efficient and high-quality data. Work with industry relations such as JPMA, PhRMA to improve PMS environment in Japan. Build good relationship with external stakeholders such as PMDA, key opinion leaders and academic society etc.
Desired Skills and Experiences:
- Behavioral Skills
- Understand and align with Pharmaceuticals and Medical Devices Law, GPSP/GVP/ GCP and SOPs, and applicable to clinical and post marketing areas
- Manage multiple projects and cross-functional processes in a timely manner
- Demonstrate quick and effective decision making
- Manage budget as planned
- Take accountability. Thrive on higher levels of responsibility by confident actions to move the business forward
- Experiences
- Experience in interventional/non-interventional study design and/or oversight of execution operations (more than 3 years' experience is preferable)
- At least 3 years' experience in Pharmaceutical Industry
- Education/Certification
- BS / MS / PhD / MD / MPH or equivalent desired
- Language
- Sufficient level of communication, negotiation, and presentation in English
- TOEIC score 700 over is preferable
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
#LI-PFE
Top Skills
Contract Research Organizations
Life Cycle Management
Post Marketing Surveillance
Regulatory Compliance
Risk Management Plan
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