Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Modern is solidifying its presence in Tokyo, a city known for its blend of tradition and innovation. Our new commercial office here will focus on bringing our advanced mRNA products to the Japanese market. Nestled in the heart of Tokyo's vibrant landscape, we're looking to integrate into the local biotech scene while contributing our global expertise. We welcome professionals who are passionate about making a difference in healthcare to join our team. Here, you'll be part of a community dedicated to simple yet profound goals: enhancing health outcomes and providing cutting-edge treatments in Japan.
As the Director, Country Head of Pharmacovigilance for Japan, you will be responsible for shaping and leading the Pharmacovigilance (PV) strategy for Moderna K.K. in compliance with Japan’s PMDA regulations and MHLW requirements. Reporting to the Pharmacovigilance Head for the Rest of World (ROW), you will lead a team of specialists based in Tokyo and collaborate cross-functionally to ensure alignment with global safety and compliance standards. This is a highly visible role with significant impact as you support the launch of Moderna's mRNA 1273 vaccine and contribute to the growth of Moderna’s portfolio in Japan. This is a unique opportunity to build and establish an industry-leading PV team in Japan and make critical contributions to Moderna’s long-term success in transforming patient care.
Here’s What You’ll Do:
Your key responsibilities will be:
Provide strategic leadership and oversight of all pharmacovigilance activities in Japan across Moderna’s portfolio.
Ensure local compliance with Individual Case Safety Reports (ICSR) and aggregate safety reporting, aligning with both local and global reporting obligations.
Lead efforts to ensure readiness for PMDA PV inspections, internal audits, and business partner audits.
Maintain robust quality management systems and business continuity plans for PV operations in Japan.
Oversee all vendors and partners performing PV activities on behalf of Moderna K.K.
Engage externally to benchmark and leverage best practices in Pharmacovigilance.
Your responsibilities will also include:
Lead the implementation of additional risk minimization measures and safety label updates in Japan.
Train all Moderna K.K. staff on Adverse Event (AE) reporting and other PV obligations.
Collaborate closely with global Clinical Safety and PV leaders to ensure local and global alignment.
Support the growth of Moderna’s portfolio in Japan, including the launch of new vaccines and therapeutics.
Drive inspection readiness and ensure the success of all local PV inspections and audits.
The key Moderna Mindsets you’ll need to succeed in the role:
Act with dynamic range: This role requires leadership across strategy, execution, and people management. You will be expected to navigate high-level strategic decision-making while ensuring flawless execution of day-to-day Pharmacovigilance activities.
Remove viscosity: In this highly visible and impactful role, you’ll need to eliminate bottlenecks and streamline collaboration across regions and functions, ensuring that PV processes are efficient, effective, and compliant.
Here’s What You’ll Bring to the Table:
Bachelor’s degree (preferably in a science or health related field) and a minimum of 10 years of experience in Pharmacovigilance, with at least 5 years of experience in Pharmacovigilance in Japan. Must have prior successful managerial experience.
Prior experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance (including PMDA PV inspections).
Significant experience with Argus-J.
Solid knowledge of PMDA regulations and MHLW requirements relevant to PV.
Significant experience working with CROs, vendors, and relationship management.
Strong managerial skills and ability to partner closely and effectively cross-functionally and cross-regionally.
Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks while working in a matrixed environment.
Ability to manage multiple projects in a fast-paced environment.
Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people and resource management)
This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should
contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.
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