Job Detail

Pharmacovigilance Specialist

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Job Summary

Jubilant DraxImage inc.
Location

Kirkland QC

Posting date

Industries

  • Pharmaceutical, Biotechnology

Categories

  • Pharmacovigilance

Maternity replacement - 15 months

Responsabilities:

  • Collect and process incoming adverse event reports from all sources.
  • Perform initial assessment of seriousness, expectedness, causality and the type of notification (rapid 15 days and/or annual).
  • Perform active follow-up to obtain missing or discrepant information.
  • Prepare expedited reports (15 days report) for submission to regulatory authorities.
  • Register incoming reports in the database.
  • Ensure appropriate documentation is filed and available for audits and inspections.
  • Perform monthly reports for QA council meeting.
  • Prepare annual summary reports.
  • Support and participate in activities related to GVP inspections.
  • Work closely with other collaborators, both within the organization and outside.
  • Support the Pharmacovigilance Leader with specific delegated tasks according to punctual needs. 

Qualifications:

  • University graduate: Life Sciences 
  • DESS in drug development and/or  RAC is an asset.
  • Experience in data entry in the software Argus
  • Minimum of one to three years in Pharmacovigilance or relevant experience in pharmaceutical industry.
  • Ability to read, analyze and interpret common scientific and technical journals.
  • Fully bilingual, excellent oral/written communication and presentation skills.
  • Phone skills, customer-oriented attitude and team player.
  • Computer skills and  practical knowledge of software applications.
  • Very well-organized, with strong ability to handle multiple tasks and to meet tight deadlines.
  • Detail-oriented, reliable, autonomy and judgment capacity toward the application of regulatory requirements.