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Pharmacovigilance (PV) Officer

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Theramex

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Location:
Poland , Warsaw

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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

Nice to have:

Familiar with EudraVigilance

What 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

Additional Information:

Job Posted:
March 19, 2026

Work Type:
Hybrid work
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