Bilingual Drug Safety Associate reviewing adverse events and quality complaints for Cencora’s Canadian patient and provider support services. Handling pharmacovigilance data, literature screening, reconciliations, and follow-up activities.
Responsibilities
Receive, scan, and document pertinent clinical information in compliance with SOPs, protocols, and applicable legislation
Work with internal and external clients to request additional information or clarification
Review source data documents, including visit reports/PIRs
Triage adverse event information and product quality complaints
Enter and submit adverse event information and product quality complaints into program-specific databases
Sort and file incoming documents
Perform quality checks on adverse event reports
Assist with or perform source data verification checks
Screen medical and scientific literature for safety information
Prepare reconciliation reports, transcription translations, and redaction activities
Prepare and conduct solicited follow-up letters and data clarifications
Assist and participate in the non-conformance/CAPA process
Perform other assigned duties and tasks as required
Requirements
Minimum college level education required
Diploma or degree with a concentration in Life Sciences is a strong asset
1–3 years of experience in Medical Information, Clinical Research, Drug Safety, or equivalent and related experience in pharmacy or pharmaceutical fields
Knowledge of the pharmacovigilance industry
Up-to-date knowledge of pharmacovigilance guidelines from Health Canada, US FDA, EMEA, and ICH
Experience in the medical and/or pharmaceutical field(s) is an asset
Knowledge of medical terminology is an asset
Bilingual English/French is required
Strong analytical skills
Effective oral and written communication skills
Effective interpersonal skills
Effective organizational skills and ability to multitask
Superior attention to detail
Ability to consistently meet deadlines
Excellent problem-solving skills
Microsoft Word, Excel, PowerPoint, and other Office programs
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