Senior Specialist, PV Operations, Global Quality Standards

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 individual contributor role supports the strategic and day-to-day operational execution of Pharmacovigilance (PV) activities related to Modernas clinical trials and post-marketing case processing. Reporting to the Director PV Operations Global Quality Standards the PV Operations Specialist will ensure the timely and compliant processing triage and quality control of Individual Case Safety Reports (ICSRs). The role acts as a key interface between clinical operations safety scientists data management and external vendors contributing directly to the global safety strategy.

This role requires hands-on knowledge of safety and clinical databases and offers a high-impact opportunity to contribute to Modernas operational excellence while engaging with global safety projects and advancing inspection readiness. A unique facet of this position is its proximity to next-generation tools and systems including opportunities to align with the latest developments in automation and Generative AI to streamline PV operations and support continuous improvement initiatives.

Heres What Youll Do:

Your key responsibilities will be:

• Support Moderna clinical trial start-up activities by developing and maintaining key safety documents including Safety Management Plans Safety Reporting Plans and SAE Reconciliation Plans.

• Provide input into safety and clinical database configuration for accurate ICSR handling.

• Manage case intake workflows: triage data entry narrative writing and quality control ensuring alignment with global regulatory requirements.

• Ensure complex or serious case elements are correctly escalated to appropriate teams.

• Monitor safety data via Electronic Data Capture systems and perform query resolution with trial sites.

• Create and maintain training content for case processing standards and ensure the PV team and vendors are aligned with current SOPs and processes.

• Maintain high-quality documentation to support inspections and audits and participate in PV compliance readiness activities.

Your responsibilities will also include:

• Act as PV Operations Lead on specific Moderna clinical protocols as needed.

• Partner cross-functionally with Global Case Management Leads Clinical Safety Scientists Medical Review Data Management and third-party Vendors.

• Contribute to SOP creation and ongoing updates ensuring compliance with global regulatory expectations.

• Participate in or lead global PV operational projects expanding Modernas operational capabilities.

• Identify and drive continuous process improvement opportunities within the Global Case Management landscape.

• Assist in training and mentoring new colleagues and vendors on case management processes and Moderna standards.

• Support workload management and proactively take on additional responsibilities as assigned by Global PV leadership.

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

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  In this operations-focused role youll be working closely with digital safety and clinical systems. Having a mindset to embrace automation digital transformation and even exploratory exposure to Generative AI will be critical as you look to streamline safety workflows and enhance global operational output.

• We obsess over learning. We dont have to be the smartest; we have to learn the fastest.
  Pharmacovigilance is a constantly evolving space. This mindset is essential to ensure that you stay current with regulatory changes safety innovations and the evolving science of patient safety all while helping Moderna maintain inspection readiness and quality excellence.

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).

• 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.

• 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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