Senior Specialist, Pharmacovigilance Global Case Management

Moderna; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Job summary

Moderna is strengthening its international business services hub in Warsaw, supporting our growing global operations. This role is an individual contributor based in Warsaw, focusing on pharmacovigilance operations and the expansion of the product portfolio.

You will ensure timely, accurate assessment and compliant triage, processing and QC of ICSRs from postmarketing and clinical trials, while coordinating with global leads, vendors and country specialists to maintain safety information

Qualifications

• University degree in Pharmacy/Medicine or other life sciences discipline.

Responsibilities

• Deliver accurate ICSR intake and processing in accordance with regulations and SOPs.
• Apply quality control to automated intake and verify data integrity.
• Coordinate with Global Case Management Leads and vendors to manage workloads.
• Oversee safety mailbox, triage, reconcile and translate safety information.
• Redact PHI-containing documents and ensure confidentiality.
• Support training, process improvements and inspections readiness.

Education

University degree in Pharmacy/Medicine or other life sciences discipline

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 ICSR(s) 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 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 optimise 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 escalat…
• Perform other tasks as assigned by global PV management.

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

"We act with urgency; Action today compounds the lives saved tomorrow." You will bring this mindset to timely case assessment, daily mailbox management, follow-up communication, and proactive escalation-moving safety information forward while maintaining the accuracy, confidentiality, and quality that compliant pharmacovigilance requires.

"We digitize everywhere possible using the power of code to maximize our impact on patients." You will apply a critical, quality-focused approach to automated intake, from checking case data to validating duplicate decisions. You will also explore opportunities to engage with Generative AI tools for training-material development and process improvement, with any use subject to appropriate approvals, data-privacy safeguards, applicable validation requirements, and human oversight.

Here's What You'll Need (Basic Qualifications):

• University degree in Pharmacy/Medicine or other relevant life sciences discipline