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.
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.
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Application from outside Canada
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