About this role
Role Overview
- Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
- Work directly with internal and external clients to request additional information or clarification
- Review of source data documents and triaging adverse event information and product quality complaints
- Data entry and submission of adverse event information and product quality complaints into program specific databases
- Sorting and filing of incoming documents
- Perform quality check on adverse event reports as directed by the work instructions
- Assist with and/or perform source data verification checks
- Screening medical and scientific literature for safety information
- Preparation of Reconciliation Reports
- Assist and participate in the non-conformance/CAPA process
Requirements
- Minimum college level education required
- A diploma or degree with a concentration in Life Sciences is a strong asset
- 1-3 years experience in Medical Information, Clinical Research or Drug Safety or equivalent
- Knowledge of Pharmacovigilance industry
- Up to date knowledge of pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH
- Bilingual, English/French is an asset
- Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary
Benefits
- Health insurance
- Dental care
- Vision care
- Paid parental leave
- Paid caregiver leave
- Backup dependent care
- Adoption assistance
- Infertility coverage
- Family building support
- Professional development resources
- Training programs
- Mentorship programs
- Employee resource groups
- Volunteer activities