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Pharmacovigilance Specialist (PL) - Poland  

Company managed [?] Still accepting applications
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Posted on : 06 April 2017

Project Description

The duties associated with the role include:
  • Performing all aspects of the processing and reporting of adverse events including electronic database entry, follow-up activities 
  • Preparing and control of the documentation related to adverse events and other safety alerts   
  • Supporting in the development of Safety Management Plans, relevant SOPs and other documents relating to pharmacovigilance system 
  • Ensuring timely preparation and distribution of adverse event reports to Regulatory Authorities, Ethics Committees and Investigators 
  • Participating in project specific internal teleconferences/meetings   

  • University/college degree (pharmacy/life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) 
  • Minimum of one (1) year of experience in pharmacovigilance/safety area   
  • Very good knowledge of ICH GCP, GVP Guideline and other ICH/EMA guidelines applicable for PV area 
  • Experience in processing safety data within Argus or another PV databases a plus but not required 
  • Very good command of English language 
  • Computer competency — MS Office environment 
  • Good planning, organization and problem solving abilities 
  • Good communication and interpersonal skills