Senior Global Pharmacovigilance Case Manager

Moderna; Województwo mazowieckie; On-site; PLN 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family benefits

Paid time off

Savings & investments

Location perks

Job summary

Moderna Warsaw is seeking a qualified pharmacovigilance specialist to support global ICSR processing. You’ll triage, process, and quality-check safety reports from postmarketing and clinical sources, ensuring confidentiality and compliance.

You will collaborate with Global Case Management Leads and vendors, managing translation tasks and redaction as needed. The role requires a science degree, PV experience, and strong communication in English.

Qualifications

• Bachelor's degree in Pharmacy, Medicine or life sciences.
• Minimum 3 years in drug safety/pharmacovigilance case processing.
• Solid knowledge of ICH PV guidelines and global PV regs (FDA/EMA/MHRA/PMDA/Health Canada).
• Experience with Argus safety database and MS Office suite (Excel, PowerPoint, SmartSheet, Visio).
• Strong time management, attention to detail, and clear communication.
• Proficiency in English (spoken and written) for global collaboration.

Responsibilities

• Deliver accurate, compliant case intake and processing for ICSRs.
• Apply quality control to automated intake and case data; manage invalid cases.
• Coordinate with Global Case Management Leads and country specialists to resolve issues.
• Oversee safety mailbox and translation activities; support triage and book-in.
• Redact PHI and manage confidential safety information during processing.
• Support follow-up, reconciliation, and cross-functional process improvements.
• Contribute to training materials and readiness activities.
• Handle multiple tasks and prioritize to maintain timely delivery.

Skills

Effective time management

Excellent communication

Proficiency in English

Education

University degree in Pharmacy/Medicine or life sciences

Tools

Argus safety database

MS Office

Excel

PowerPoint

SmartSheet

Visio

Job description

Moderna Warsaw is seeking a qualified pharmacovigilance specialist to support global ICSR processing. You’ll triage, process, and quality-check safety reports from postmarketing and clinical sources, ensuring confidentiality and compliance.

You will collaborate with Global Case Management Leads and vendors, managing translation tasks and redaction as needed. The role requires a science degree, PV experience, and strong communication in English.