Specialist, Pharmacovigilance Operations

If youre interested in this role please apply in English and include an English version of your CV.

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.

This Warsaw-based Pharmacovigilance Specialist position will support Modernas global case processing operations for clinical trial safety reports. Reporting to the Director PV Operations Case Processing the successful candidate will be responsible for triaging processing and quality control of individual case safety reports (ICSRs) submitted during Modernas clinical studies. This role centers on accurate entry and documentation of adverse events including composing detailed medical narratives and ensuring compliance with regulatory expectations. You will play a crucial part in supporting our mRNA-1273 COVID-19 vaccine launch and the acceleration of Modernas late-stage pipeline. With substantial growth ahead this position offers the opportunity to work with cutting-edge pharmacovigilance tools and contribute directly to patient safety across pivotal trials.

Heres What Youll Do:

Your key responsibilities will be:

• Reviewing ranking verifying processing and documenting case-related information including adverse event terms seriousness special scenarios and timelines

• Performing quality control to ensure accuracy and consistency across all safety case submissions

• Using source documents to author comprehensive and medically appropriate narratives for clinical adverse events

• Processing safety data in alignment with global regulations internal SOPs and company standards

Your responsibilities will also include:

• Supporting inspection readiness initiatives across the PV case processing function

• Contributing to training and mentoring efforts for new colleagues in Warsaw

• Participating in continuous improvement projects aimed at enhancing process efficiency and data integrity

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.
  With evolving clinical programs and regulatory expectations your ability to continuously learn and apply new knowledge will be essential to ensure the highest standards in safety case reporting.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  As Moderna continues to automate and scale its pharmacovigilance operations youll work alongside advanced tools and digital solutionsincluding those linked to Generative AIto help transform how we manage patient safety at scale.

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 2 years 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

• Proficiency in English (verbal and/or written) required due to global collaboration needs.

Pay & Benefits

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.

• Best-in-class healthcare plus voluntary benefit programs to support your unique needs

• A holistic approach to well-being with access to fitness mindfulness and mental health support

• Family building benefits including fertility adoption and surrogacy support

• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown

• Savingsandinvestments to help you plan for the future

• 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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