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Pharmacovigilance Officer (PVO) - Sweden, Denmark, 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