info@irwcro.com | +46 8 791 66 40

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 IRW’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