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Pharmacovigilance Officer (PVO) 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 3 years of Pharmacovigilance experience in the Pharmaceutical/CRO industry  
  • strong knowledge of gcp/ICH guidelines and other applicable regulatory requirements. 
  • 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  
  • position may require 4-5 days/week travel both national and international. 
  •  valid driving license. 
  • workplace at company s or sponsor s office. 


principal duties
  • write detailed description of the Pharmacovigilance system 
  • 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 
  • seriousness, expectedness and causality assessment 
  • qc of database entry 
  • 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 
  • provide  Training for colleagues on Pharmacovigilance, administrative, and company procedures and processes  
  • demonstrate willingness to take on any level project activity consistent with current or past experience 
  • participate in audits and inspections 
  • assist with company s Quality Control initiative 
  • participate in company-required Training/conference programs 

Locations

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

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