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.

In this critical role as a Senior Specialist, PV Operations – Global Quality Standards, you will be responsible for executing key activities related to the initial assessment, processing, and quality control of individual case safety reports (ICSR) from Moderna clinical trials. Your contributions will ensure timely and accurate assessment of adverse event reports, which is crucial for maintaining the highest standards of safety in our clinical operations. You will operate on both the Clinical and Safety databases, proactively managing and requesting information from trial sites and discussing significant adverse events with the Clinical Safety and Risk Management team. Your role will also encompass supporting clinical trial start-up activities, developing and updating essential safety documentation, and collaborating closely with various stakeholders to ensure seamless integration and execution of safety protocols.

Here's What You’ll Do:

Your key responsibilities will be:

• Clinical Trial Support: Lead efforts in supporting Moderna clinical trial start-up activities, including the development and continuous update of safety documentation such as the Safety Management Plan (SMP), Safety Reporting Plan (SRP), and SAE Reconciliation Plan. You will provide critical input to the configuration of safety and clinical databases to facilitate effective ICSR processing.
• Case Processing and Management: Oversee the triage and quality control of ICSRs, ensuring that each report is reviewed, ranked, verified, and processed in accordance with global regulatory requirements, guidelines, and SOPs. You will craft comprehensive narratives for adverse events and manage the follow-up process with clinical trial sites as needed.
• Collaboration and Coordination: Work closely with Global Case Management Leads, Medical Review Physicians, Clinical Safety Scientists, Data Management, and Vendors to ensure the highest level of safety oversight. You may also act as the PV Operations Lead for specific Moderna protocols and contribute to global PV projects.
  
  
  

Your responsibilities will also include:

• Training and Mentoring: Collaborate with the Global PV Operations team to create and update training materials, ensuring that case management standards are clearly understood and adhered to. You will mentor new colleagues and assist in training both the Global Case Management team and vendors.
• Process Improvement and Compliance: Continuously identify and address gaps in current processes, contributing to the development of improved Global Case Management SOPs. You will support inspection readiness activities and ensure that all procedures comply with regulatory standards.
  
  
  

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

• Prioritize the Platform: This role requires a deep understanding of how your contributions fit into the broader mission of Moderna. By focusing on platform-based improvements and ensuring that all safety processes are robust and scalable, you will help drive the success of Moderna's mRNA technology.
• Question Convention: As a Senior Specialist, you will be expected to challenge existing norms and continuously seek innovative solutions to complex safety challenges. Your ability to question conventional approaches and propose new methods will be vital in advancing Moderna's commitment to safety and efficacy in clinical trials.
  
  
  

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).
• At least 2-3 years of experience in drug safety/pharmacovigilance case processing.
• Proficiency with Argus safety database and other platforms, MS Office suite, Excel, PowerPoint.
• Solid knowledge of ICH guidelines relevant to PV and global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada.
• Experience in clinical trial set-up within PV.
• Demonstrated ability to develop, execute, and follow through on complex projects to completion.
• Skilled at working effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
• Independently motivated, detail-oriented, and strong problem-solving ability.
• Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities.
• Excellent written and verbal communication skills.
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to identify issues and raise to line management in order to develop relevant plans and recommendations.
• Fluency in English required.
  
  
  

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 leavesandaccommodations@modernatx.com.

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