Safety Officer (Pharmacovigilance) – Poland

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

Job description

 

Responsibilities

  • 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.

At EXCELYA sustainable careers flourish, as we care about what you can be and how fast you can reach higher international positions.

 

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