Drug Safety Associate, Bilingual – French

This is a fully remote position, open to applicants in Canada.

📋 Description

• Receive, scan, and document relevant clinical information in accordance with SOPs, protocols, and applicable regulations.

• Collaborate with internal and external clients to obtain additional information or clarification as needed.

• Review source data documents, including visit reports and PIRs.

• Triage information on adverse events and product quality complaints.

• Input and submit adverse event details and product quality complaints into program-specific databases.

• Organize and file incoming documents systematically.

• Conduct quality checks on adverse event reports.

• Assist with or execute source data verification checks.

• Screen medical and scientific literature for safety-related information.

• Generate reconciliation reports, transcription translations, and manage redaction activities.

• Draft and send solicited follow-up letters and data clarifications.

• Support and engage in the non-conformance/CAPA process.

• Carry out other assigned responsibilities and tasks as necessary.

⛳️ Requirements

• A minimum of a college-level education is required.

• A diploma or degree focused on Life Sciences is highly advantageous.

• 1–3 years of experience in Medical Information, Clinical Research, Drug Safety, or similar relevant experience in pharmacy or pharmaceutical sectors.

• Familiarity with the pharmacovigilance industry.

• Current knowledge of pharmacovigilance guidelines from Health Canada, US FDA, EMEA, and ICH.

• Experience in the medical and/or pharmaceutical fields is beneficial.

• Understanding of medical terminology is advantageous.

• Bilingual proficiency in English and French is mandatory.

• Strong analytical capabilities.

• Proficient oral and written communication skills.

• Strong interpersonal abilities.

• Excellent organizational skills and the capacity to multitask.

• Exceptional attention to detail.

• Ability to consistently meet deadlines.

• Excellent problem-solving abilities.

• Proficiency in Microsoft Word, Excel, PowerPoint, and other Office applications.

• Reliable internet connection is required for remote work.

🏝️ Benefits

• Medical, dental, and vision care.

• Backup dependent care.

• Adoption assistance.

• Infertility coverage.

• Family building support.

• Behavioral health solutions.

• Paid parental leave.

• Paid caregiver leave.

• Training programs.

• Professional development resources.

• Mentorship programs.

• Employee resource groups.

• Volunteer opportunities.

• Remote work arrangements.