Safety Officer (Pharmacovigilance) – Poland

Excelya>Full-time>Safety Officer (Pharmacovigilance) – Poland

Job description



  • Ensure Individual Case Safety Report case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
  • The role holder may be expected to support and ensure case management and related activities for other countries within the EMEA Region (centralized case management) are carried out in a timely manner.
  • Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
  • Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
  • Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
  • Data entry for complex cases (seek support from senior specialist as applicable)
  • Performing follow-up for requesting additional information from multiple sources.
  • Assist in the quality review of data captured in the GIRS as applicable
  • Verify and ensure translation of safety information, if applicable.
  • Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
  • escalation non-conformance in a timely manner.
  • Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, materiovigilance, or cosmetovigilance (as applicable).
  • Agregate Reporting
  • Compliance Monitoring
  • Audit/inspection preparation and support
  • Other activities related to case management activities.

Requirements :

    • substantial pharmaceutical or contract research organization background
    • 1-2 years experience in pharmacovigilance and patient safety
    • Based in Poland (as to allow visits to the client’s affiliate when needed)
    • Around 10 hours per month is our initial estimate for steady phase for this one project (more time during onboarding due to trainings
    • Availability : immediately


Join us for a challenging career!

The company offers a competitive remuneration package, as well as continuous development and rewarding career opportunities in an exciting, international and supporting working environment.

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