Specialist, Global Case Management

Posted 2 Days Ago
Be an Early Applicant
2 Locations
In-Office
Junior
Healthtech • Biotech
The Role
As a Global Case Management Specialist, you'll process Individual Case Safety Reports ensuring accuracy and compliance, while supporting pharmacovigilance initiatives and engaging in continuous improvement efforts.
Summary Generated by Built In

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 Specialist, Global Case Management, you will play a key role in ensuring timely, high-quality processing of Individual Case Safety Reports (ICSRs) for Moderna’s clinical trials. With a strong focus on accuracy, narrative development, and regulatory compliance, you’ll support global pharmacovigilance activities that directly impact patient safety. This role offers an opportunity to work closely with innovative safety systems and processes, while gaining exposure to cutting-edge drug development and the evolving field of mRNA medicine. Based in Warsaw, this individual contributor role also positions you close to operational excellence initiatives and the opportunity to engage with Generative AI tools to support documentation and case processing innovation.

Here’s What You’ll Do:

Your key responsibilities will be:

  • Review, rank, verify, process, and document ICSR information including event terms, seriousness, special scenarios, and timelines.

  • Write comprehensive case narratives using source documentation that accurately reflect reported adverse events.

  • Perform ICSR triage and quality control in accordance with global regulatory standards.

  • Ensure safety data are processed per applicable regulations, guidelines, SOPs, and internal requirements.

  • Support inspection readiness and compliance initiatives by maintaining data integrity and case quality.

  • Contribute to internal meetings, representing Case Safety & Pharmacovigilance (CS&PV) functions.

Your responsibilities will also include:

  • Assist in onboarding and mentoring new colleagues as needed.

  • Engage in continuous improvement initiatives to enhance efficiency and effectiveness in safety operations.

  • Prioritize multiple concurrent projects and escalate issues proactively.

  • Contribute to team discussions and presentations as required.

  • Complete any additional assignments delegated by Global Pharmacovigilance Management.

The key Moderna Mindsets you’ll need to succeed in the role:

  • “We digitize everywhere possible using the power of code to maximize our impact on patients.”
    This mindset aligns directly with opportunities in this role to explore automation and leverage emerging digital tools, including Generative AI, to improve case processing accuracy and efficiency.

  • “We obsess over learning. We don’t have to be the smartest we have to learn the fastest.”
    Given the evolving landscape of global pharmacovigilance and regulatory expectations, rapid learning and adaptation will be key to maintaining Moderna’s quality standards and operational excellence.

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 1 year of experience in drug safety/pharmacovigilance case processing

  • Medical Writing experience preferred

  • Argus safety database and other platforms MS Office suite, Excel, Powerpoint, 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.

  • 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
  • Savings and investments
  • 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, 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 [email protected]

-

Top Skills

Argus Safety Database
Excel
Generative Ai
MS Office
PowerPoint
Visio
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
Cambridge, Massachusetts
6,848 Employees
Year Founded: 2010

What We Do

At Moderna, we believe messenger RNA, or mRNA, is the “software of life.”

Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease.

Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching and could meaningfully improve how medicines are discovered, developed and manufactured.

To learn more, visit www.modernatx.com.

This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762).

Similar Jobs

In-Office
2 Locations
6848 Employees

Moderna Logo Moderna

Research Associate

Healthtech • Biotech
In-Office
2 Locations
6848 Employees
63K-101K Annually
In-Office
2 Locations
6848 Employees
In-Office
2 Locations
6848 Employees

Similar Companies Hiring

Axle Health Thumbnail
Logistics • Information Technology • Healthtech • Artificial Intelligence
Santa Monica, CA
17 Employees
Camber Thumbnail
Social Impact • Healthtech • Fintech
New York, NY
53 Employees
Sailor Health Thumbnail
Telehealth • Social Impact • Healthtech
New York City, NY
20 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account