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Pharmacovigilance Associate (PVA) Sweden, København Denmark, Vantaa Finland, Norway,  

IRW (company)

Posted on : 10 July 2017

Project Description

desirable qualifications and background
  • academic degree in Natural science such as Life Sciences, Pharmacy or Nursing
  • at least 1 years of Pharmacovigilance experience in the Pharmaceutical/CRO industry  
  • strong knowledge of ICH guidelines and other applicable regulatory requirements  
  • strong interpersonal skills and the ability to build relationships both internally and externally 
  • computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint 
  • good ability to express yourself both verbally and in writing 
  • good knowledge of spoken and written English 
  • good organizational skills 
  • a service-minded approach 
  • a well developed understanding for the Consultant role 
  • valid driving license 
  • position requires occasional travel both national and internationally  
  • workplace at company s or sponsor s office 

principal duties
  • collect and review adverse drug reactions (adr) /Adverse Events
  • duplicate check and database entry of adr and sae in the internal safety database 
  • MedDRA coding 
  • report safety information to regulatory authorities (european countries and usa) 
  • worldwide literature search 
  • draft periodic safety update reports (psur) and annual safety reports 
  • support clients in the eudravigilance registration process 
  • eudravigilance Testing 
  • register products in eudravigilance medicinal product dictionary  
  • archiving of Pharmacovigilance documents 
  • participate in audits and inspections 
  • assist with company s Quality Control initiative 
  • participate in company-required Training/conference programs 


182 17 Danderyd Sweden1310 København K DenmarkRajatorpantie 41 01640 Vantaa FinlandNO 1366 Lysaker Norway

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