Global Pharmacovigilance Case Manager

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

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.