The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team

thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working

alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas 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 Modernas global business operations. Were 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 Modernas 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 redactionensuring 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.

Heres What Youll 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 youll need to succeed in the role:

• We obsess over learning. We dont 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.

Heres What Youll 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

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work at home and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness nutrition and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savingsandinvestments
• Location-specific perks and extras!

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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 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 persons 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.

Were 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 .

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