Location: Warsaw / Hybrid

About You

• You hold a Bachelor's or Master's degree in Life Sciences.
• You bring a minimum of 2 years' experience in Case Processing and/or Drug Safety/Pharmacovigilance, with solid knowledge of global PV regulations.
• You are detail‑oriented, organised, confident with medical terminology, and able to communicate effectively in English (written and spoken).
• You're experienced in using safety databases and familiar with EudraVigilance (advantage).
• You can multitask, manage projects, work independently as well as collaboratively, and are eligible to work in Poland.

About the Role

As a Pharmacovigilance (PV) Officer, you will play a key role within our Global Theramex Pharmacovigilance Team, based in our Warsaw HQ. This position provides hands-on experience across multiple areas of Pharmacovigilance, contributing directly to patient safety and product quality.

Your responsibilities will include:

• 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.

What does our team say about life at Theramex?

"Theramex is committed to women's health and is making a huge positive impact to women's lives. I feel this daily in my interactions in the field. It fuels my passion to contribute as I can see, feel, and hear the impact in my area. How does it make me feel? Empowered and proud!"
- Claire Holmes, Women's Health Account Manager

Why Join Us?

Be part of a dynamic team at Theramex, where you'll have the opportunity to make a significant impact on women's health. We offer:

• 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.

If you're passionate about making a difference and meet the qualifications, we'd love to hear from you. Apply today to join our team at Theramex.