Pharmacovigilance (PV) Officer

• Performing full and accurate case processing, including triage, MedDRA coding, seriousness assessment, narrative writing, and data entry into the global safety database in line with SOPs and regulatory requirements
• Managing ICSR follow-ups and submitting ICSRs to various Health Authorities
• Conducting AE/SAE reconciliation
• Performing global literature reviews using tools such as Embase and MLM service
• Handling EudraVigilance activities, including downloading and submitting ICSRs
• Supporting the maintenance and use of the global safety database
• Contributing to signal detection and risk management activities under guidance from senior team members and PV Physicians
• Supporting development of PV and Regulatory documents (e.g., PSURs, RMP, RSI, HA responses) as required
• Contributing to the preparation of the Theramex PSMF
• Participating in PV audits and inspections
• Contributing to enhancements of SOPs, working practices, and PV processes
• Processing PV-related deviations and CAPAs
• Performing other tasks reasonably aligned with the scope of this role

• Bachelor’s or Master’s degree in Life Sciences
• Minimum of 2 years’ experience in Case Processing and/or Drug Safety/Pharmacovigilance, with solid knowledge of global PV regulations
• Detail‑oriented, organised, confident with medical terminology
• Able to communicate effectively in English (written and spoken)
• Experienced in using safety databases
• Familiar with EudraVigilance (advantage)
• Can multitask, manage projects, work independently as well as collaboratively
• Eligible to work in Poland

Familiar with EudraVigilance

• A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
• Support for your continued growth, learning, and development, with celebration of success and recognition of performance
• Opportunities for driven and talented professionals who want to be part of our exciting journey