Specialist PV Operations

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.

Moderna is seeking a Specialist PV Operations Case Processing to join our team in Warsaw Poland. Reporting to the Director PV Operations Case Processing this individual will play a crucial role in the processing and quality control of individual case safety reports (ICSRs) from Modernas pivotal clinical trials. The Specialist will be responsible for ensuring accurate triage entry and documentation of adverse events in compliance with regulatory guidelines and company procedures. As Moderna continues to expand its latephase development pipeline this role offers an exciting opportunity to contribute to the safety and success of innovative mRNAbased therapeutics.

Heres What Youll Do:

Your key responsibilities will be:

• Review rank verify process and document caserelated information including event terms validity seriousness and special scenarios.

• Conduct timely and accurate case processing based on regulatory requirements and company procedures.

• Write detailed and comprehensive narratives to describe adverse events reported in clinical trials using source documents.

• Ensure adherence to pharmacovigilance regulations standard operating procedures (SOPs) and company policies in case processing activities.

Your responsibilities will also include:

• Contributing to mentoring and training new colleagues in case processing procedures as needed.

• Supporting continuous improvement initiatives to enhance efficiency and accuracy in safety case processing.

• Assisting with inspection readiness activities to ensure compliance with global regulatory standards.

The key Moderna Mindsets youll need to succeed in the role:

• We obsess over learning In pharmacovigilance accuracy is critical. This role requires continuous learning to stay ahead of evolving regulations new safety data and best practices in case processing. Your ability to absorb new information quickly and apply it effectively will be key to success.

• We remove viscosity Efficient and timely case processing is essential in clinical trials. This role will require you to proactively remove barriers streamline processes and facilitate clear and rapid decisionmaking to ensure compliance with safety reporting timelines.

Heres What Youll 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 1 year 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

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and wellbeing 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 wellbeing
• 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 yearend shutdown
• Savingsandinvestments
• Locationspecific 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 worldclass 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 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 nondiscrimination 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 .