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Pharmacovigilance Lead/Manager (PL) - Poland  

KCR (company)


Posted on : 08 June 2017

Project Description

The duties associated with the role include:      
  • Overseeing toward the active portfolio of clinical trials where PV services are contracted (ensuring compliance with GCP and relevant country and international regulations). 
  • Managing of safety associates, including workload management. 
  • Performing EudraVigilance registration and reporting. 
  • Collaborating with global regulatory affairs and operations to ensure timely submission of SUSAR to authorities and investigators. 
  • Managing and overseeing of PV systems. 
  • Representing the company during subject matter conferences and industry events.  

  • University/college degree (life science preferred) 
  • Minimum of three (3) year of clinical research experience and minimum one (1) year in pharmacovigilance/safety area   
  • Very good knowledge of GVP, GCP, local regulatory requirements, ICH Guidelines, European Directives 
  • Ability to work independently and efficiently according to local regulations, SOP, ICH GCP, GVP, EU Directives 
  • Experience in processing safety data within Argus or another PV databases a plus 
  • Very good command of English language 
  • Computer competency — MS Office environment 
  • Good planning, organization and problem solving abilities 
  • Good communication and interpersonal skills 
  • Good analytical and negotiation skills