Pharmacovigilance Specialist

Position Summary

Pharmacovigilance Specialist will provide technical and case processing related expertise to safety management of clinical trials, ensuring compliance with relevant regulations and Standard Operating Procedures.

Key Activities and Responsibilities

  • Triage of incoming reports for completeness, version and validity
  • Tracking and filing of incoming reports
  • Data entry of case reports into the Safety Database
  • Preparation of case narratives
  • Initial assessment of case reports for seriousness, causality and expectedness
  • Case reconciliation, incl. query management and coordination with Data Management personnel
  • Expedited and periodic line listing preparation 
  •  Communication and cooperation with investigational sites and project team members
  • Maintain project specific working files, case files and project central files
  • Monthly status reporting to line manager
  • Regular data quality checks of safety data
  • TMF archiving of safety-related documentation

Competences, Skills and Qualification

  • Relevant degree (e.g. medicine, nursing, pharmacy, life sciences or other health-related field) or equivalent qualification
  • Clinical trial knowledge with at least 3-year prior experience in clinical research industry and preferably at least 1-year prior experience in pharmacovigilance / safety area of clinical trials
  • Competent user of MS Office (Work, Excel), MS Outlook and Internet user
  • Written and oral fluency in English language
  • Advanced computer literacy with database handling skills
  • Detail-oriented, accountable with end-oriented work capacity
  • Good Clinical Practice knowledge and understanding of its principles

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