Senior Specialist, Global Case Management

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.

The Senior Specialist, Global Case Management will be integral to Moderna’s commitment to safety and innovation in clinical trials. This individual will ensure the accurate assessment, processing, and quality control of individual case safety reports (ICSRs) from Moderna's clinical trials. They will also play a pivotal role in clinical trial start-up activities, including developing and updating essential safety documentation, configuring safety databases, and collaborating with cross-functional teams. This role extends beyond standard tasks, offering opportunities to create and update training materials, mentor new colleagues, and lead or participate in global pharmacovigilance projects.

Here’s What You’ll Do:

Your key responsibilities will be:

• Proactively supporting Moderna clinical trial start-up activities.

• Developing and updating clinical trial safety documentation, such as SMPs, SRPs, and SAE Reconciliation Plans.

• Providing input for safety and clinical database configurations to ensure efficient ICSR management.

• Collaborating with Global Case Management Leads, Medical Review Physicians, Clinical Safety Scientists, Data Management, and Vendors.

• Writing comprehensive narratives for adverse event reports and ensuring their alignment with source documentation.

• Ensuring compliance with regulations, guidelines, SOPs, and Moderna standards for safety data processing.

Your responsibilities will also include:

• Leading or participating in global pharmacovigilance projects.

• Coordinating workflow and daily activities for case processing teams, as needed.

• Acting as PV Operations Lead for Moderna protocols when required.

• Mentoring and training new colleagues while contributing to the creation of training materials.

• Supporting inspection readiness activities and driving continuous improvement initiatives.

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

• We act with urgency: The nature of clinical trial safety and adverse event management demands swift action to protect patients and ensure compliance with global safety regulations.

• We obsess over learning: As global regulations and best practices evolve, staying ahead through continuous learning will be crucial for success in this role.

Here’s What You’ll Bring to the Table:

• Fluency in English required

• 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

• Experience in clinical trial set-up within PV

• 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

• 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:

• 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, and a discretionary year-end shutdown
• Educational resources
• 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 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 [email protected].

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