Location: Warsaw / Hybrid

About You

• You hold a BSc or MSc in Life Sciences.
• You bring over 5 years’ experience in Drug Safety/Pharmacovigilance with strong understanding of global PV regulations and GVP modules.
• You have a proven track record in planning and authoring safety documents (e.g., PSURs, RMPs), with excellent medical writing skills and impeccable attention to detail.
• You have experience leading strategy formulation, managing multiple projects, and navigating change.
• You’re confident with medical terminology, skilled in communication, highly organised, and comfortable working in rapidly evolving environments.
• You can work independently and as part of a team, prioritising effectively while managing diverse tasks.
• You are fully proficient in English (spoken and written).

About the Role

As a Pharmacovigilance Manager within our Global Theramex Pharmacovigilance Team based in Warsaw HQ, you will provide strategic and operational pharmacovigilance expertise. This is a hands-on role with responsibility for safety surveillance, risk management, compliance, and authoring of key PV documents—especially aggregate safety reports.

Your responsibilities will include:

• Leading global aggregate safety reporting (planning, authoring, compliance).
• Performing signal detection and risk management activities, providing clear recommendations and prioritising mitigation actions that add value for patients.
• Producing high‑quality aggregated data reviews and signal evaluations with clear conclusions and actions.
• Authoring and/or reviewing PV and regulatory documents (e.g., PSURs, RMPs, RSI, HA responses) and contributing to study protocols.
• Monitoring PV compliance (including ICSRs, aggregate reports, and safety variations).
• Contributing to the preparation and maintenance of the Pharmacovigilance System Master File (PSMF).
• Enhancing PV processes by reviewing and creating SOPs, Work Instructions, and procedural documents.
• Supporting case processing activities (data entry, coding, reconciliations, QC, reporting).
• Mentoring and training junior colleagues, and delivering PV training to project teams or external partners.
• Participating in the negotiation and execution of PV agreements.
• Supporting and participating in PV audits and inspections as required.
• Performing any other responsibilities reasonably aligned with this role.

What does our team say about life at Theramex?

“Having now been with Theramex for a few months, I’m really enjoying my time here. Right from the outset, the onboarding experience, induction, and orientation have been brilliant, and I already feel like I am making the most of opportunities to add value to the business in meaningful ways. Theramex has a friendly and supportive vibe and is a place where I feel supported and valued.”

Umut Tarakcilar, Senior Treasury Analyst

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.

Apply Now!

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.