Responsibilities

  • Data entry of vigilance cases in the relevant databases
  • Preparation of initial email (in the context of follow up request), requests for clarification
  • Submission of cases to the competent authorities
  • Carrying out specific queries in the databases in order to draft reports
  • Monitoring and downloading ICSRs in the national databases (Eudravigilance, MHRA portal)
  • Monitoring a generic mailbox and support in the registration and the initial triage in the database
  • Quality control of vigilance cases
  • Recordings/updates on XEVMPD
  • Drafting/updating of technical agreements /safety management plan /client template
  • Drafting/updating of SOPs/WPDs/Trainings others documents directly related to their activity
  • Participation in the implementation/maintenance/improvement of processes

Education & Experience

  • Bachelor’s degree in science related field
  • Fresher or 1 year of PV experience
  • Well versed with Outlook and Microsoft Office

Skills

  • Database experience preferred
  • Process oriented
  • Enjoys working with documentation
  • Good computer skills
  • Works well within a team
  • Knowledge of medical terminology
  • Organized
  • Flexible
  • Excellent communication skills in English and French

Publish Date

29 July, 2024

Spontaneous Application

Data Officer 340-343/382

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