Senior Specialist, Pharmacovigilance Global Case Management

Moderna Therapeutics; Warszawa; On-site; PLN 90,000 - 120,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being programs

Family building benefits

Generous paid time off

Savings and investments

Job summary

Moderna Therapeutics in Warsaw is hiring an individual contributor to support global pharmacovigilance operations. You will triage, process, and ensure quality control of adverse event reports from postmarketing and clinical trial sources.

You will collaborate with Global Case Management Leads and vendors to manage workloads, maintain translation and safety mailboxes, and ensure compliance with regulatory requirements. A degree in life sciences and 3+ years PV experience are required.

Qualifications

• University degree in Pharmacy/Medicine or other life sciences.
• Minimum 3 years of experience in drug safety/pharmacovigilance case processing.
• Solid knowledge of ICH guidelines and global PV regulations (FDA, EMA, MHRA, PMDA, Health Canada).

Responsibilities

• Deliver accurate, compliant case intake and processing.
• Maintain case entry and organize source documents in Argus.
• Perform quality control of automated intake and case data.
• Coordinate with Global Case Management Leads and vendors.
• Protect confidential information and redact PHI as required.
• Support translation activities and safety mailbox operations.

Skills

Time management

Communication

English

Education

University degree in Pharmacy/Medicine or life sciences

Tools

Argus safety database

MS Office

Excel

Job description

The Role Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international business services hub in Warsaw, supporting our growing global operations. We welcome professionals ready to help advance our mission and shape the future of mRNA medicines. In this role, you will be an individual contributor based in Warsaw, Poland, supporting global pharmacovigilance (PV) operations and Moderna’s expanding product portfolio. You will deliver timely, accurate assessment and compliant, high-quality triage, processing, and quality control of individual case safety reports (ICSRs) received from postmarketing and/or clinical trial sources. Working with Global Case Management Leads and vendors in a fast-paced, dynamic environment, you will help oversee workloads, strengthen training, and support global projects while maintaining the accuracy and confidentiality of safety information.

Here’s What You’ll Do

• Deliver accurate, compliant case intake and processing.
• Review source documents received from postmarketing and/or clinical trial sources to triage and book in IC SRs according to applicable regulations, guidelines, Standard Operating Procedures (SOPs), and company requirements.
• Maintain accurate case entry and attach and organize source documents and correspondence in the Argus database, supporting timely assessment and high-quality processing of adverse event reports.
• Apply rigorous quality control to automated intake and case management.
• Review cases received through Moderna’s intake tool to perform exception handling, conduct quality control of automated case data, and validate automated duplicate decisions.
• Manage invalid cases and support case deletion and merge activities.
• Coordinate across global stakeholders to resolve issues and manage workloads.
• Liaise with Global Case Management Leads and country specialists to elevate and resolve country-specific issues, including health authority download concerns.
• Collaborate with Global Case Management Leads and vendors to oversee workload management and support global projects.
• Keep safety-mailbox and translation activities running reliably.
• Oversee the Drug Safety mailbox, ensuring emails are triaged, acknowledged, reconciled, filed, and addressed daily.
• Coordinate translation activities during triage and book-in, and oversee the Translation mailbox to support the timely handling of safety information.
• Protect confidential information throughout the case-management process.
• Perform diligent redaction of source documents and outbound follow-up documentation containing protected health information (PHI).
• Manage the processing, translation, and redaction of safety information received from Moderna’s legal affiliates.
• Drive consistent follow-up and thorough reconciliation.
• Manage outbound postal follow-up requests for non-US regions and send electronic follow-up requests daily.
• Perform and oversee ICSR reconciliation with business and internal partners.
• Liaise cross-functionally to troubleshoot and optimize processes related to follow-up, redaction, and reconciliation.
• Strengthen training, continuous improvement, and inspection readiness.
• Work proactively with Global Case Management Leads and vendors to create and update training materials.
• Contribute to mentoring and training new colleagues as needed, support continuous improvement opportunities and inspection readiness activities, and contribute to presentations and discussions.
• Manage competing priorities with sound judgment.
• Perform multiple tasks simultaneously, prioritize competing requests and projects, and escalated issues as appropriate to maintain timely, accurate, and compliant delivery.
• Perform other tasks as assigned by global PV management.

Here’s What You’ll Need (Basic Qualifications)

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

Our Working Model

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. Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Pay & Benefits

• Competitive 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.
• Savings and investments 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, 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. 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 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 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 consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re 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 [e-mail].

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.