The Role
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.
Moderna is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions, meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.
As a Senior Specialist in Global Case Management, you will play a pivotal role in Moderna’s expanding pharmacovigilance function, managing the end-to-end lifecycle of Individual Case Safety Reports (ICSRs) from a variety of sources, both postmarketing and clinical. This Warsaw-based individual contributor role is embedded within a global safety operations model and involves direct collaboration with Case Management Leads, vendors, and internal stakeholders. You will drive operational excellence in case triage, exception handling, source documentation, and redaction—ensuring regulatory compliance, accuracy, and timely execution. Additionally, you will support global projects, contribute to training materials, optimize mailbox and translation workflows, and serve as a subject matter expert for inspection readiness and continuous improvement.
Here’s What You’ll Do:
Your key responsibilities will be:
Triage and process ICSRs in compliance with global regulatory requirements, SOPs, and internal quality standards
Review source documents and automated case data, performing quality control and validating duplicate detection
Manage daily operations of the Drug Safety mailbox and Translation mailbox, ensuring timely triage, acknowledgment, and reconciliation
Perform redaction of source documents and follow-up communications to remove protected health information (PHI)
Coordinate with Global Case Management Leads and country-level teams to resolve case intake issues, translation requests, and submission readiness
Monitor and support postal and electronic outbound follow-up processes for global regions
Your responsibilities will also include:
Oversee reconciliation of ICSRs with business/internal partners and handle invalid case management, deletion, and merge activities
Maintain and organize safety data in the Argus database, ensuring accurate attachment and traceability of source documents
Liaise cross-functionally to improve workflows for redaction, follow-up, and case reconciliation processes
Support onboarding and mentoring of new colleagues, and contribute to the development of training materials
Participate in inspections and audit readiness initiatives, bringing a mindset of continuous improvement
Contribute to team presentations and discussions, while managing multiple tasks in a dynamic, fast-paced environment
The key Moderna Mindsets you’ll need to succeed in the role:
“We obsess over learning. We don’t have to be the smartest we have to learn the fastest.” In a constantly evolving regulatory and scientific landscape, your ability to absorb new PV requirements, platform tools, and automation capabilities will be critical. You will be expected to learn rapidly and translate that knowledge into compliant, quality-focused case management.
“We digitize everywhere possible using the power of code to maximize our impact on patients.” This role sits at the intersection of data, safety operations, and digital automation. You will work with systems that apply automation to case intake and triage and have opportunities to help refine technology-driven safety processes, potentially integrating future GenAI tools to further enhance accuracy and efficiency in pharmacovigilance.
Here’s What You’ll Bring to the Table:
University degree in Pharmacy/Medicine or other relevant life sciences discipline (Dentistry, Experimental Medicine, Microbiology, Veterinary, Biotechnology, Physiotherapy, Medical Biology or similar)
Minimum 3 years of experience in drug safety/pharmacovigilance case processing
Solid knowledge of ICH guidelines relevant to PV and of global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada
Argus safety database and other platforms MS Office suite, Excel, Powerpoint, SmartSheet, Visio
Effective time management skills
Excellent communication skills (verbal and writing); results oriented and strong attention to detail
Fluency in English required
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
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 opportunity in employment 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 consider qualified applicants regardless of criminal histories, consistent with legal requirements.
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodation 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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