About the role

Drug Safety Associate supporting Cencora’s Canadian patient and provider programs. Processing adverse events, quality complaints, clinical data, and pharmacovigilance reports.

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 report/PIR reviews
Triage adverse event information and product quality complaints according to client needs
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 according to work instructions
Assist with and/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

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 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
Adaptability to change and willingness to learn new skills as required
Experience in medical and/or pharmaceutical fields; medical terminology is an asset
Bilingual English/French is an asset
Strong analytical skills
Effective oral and written communication skills
Effective interpersonal skills
Effective organizational skills and ability to multitask
Superior, proven attention to detail
Ability to consistently meet deadlines
Excellent problem-solving skills
Computer skills, including Microsoft Word, Excel, PowerPoint, and other Office programs
Good internet required for remote work