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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 IRW’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