Drug Safety Associate

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

📋 Description

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

• Collaborate with internal and external clients to obtain further information or clarification as necessary.

• Examine source data documents, including visit reports and PIR reviews.

• Categorize adverse event information and product quality complaints based on client requirements.

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

• Organize and file incoming documents efficiently.

• Conduct quality checks on adverse event reports following established work instructions.

• Assist with and/or execute source data verification checks.

• Review medical and scientific literature for safety information.

• Create reconciliation reports, manage transcription translations, and handle redaction tasks.

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

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

• Perform other assigned responsibilities and tasks as needed.

⛳️ Requirements

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

• A diploma or degree with a focus on Life Sciences is a significant advantage.

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

• Familiarity with the pharmacovigilance industry.

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

• Flexibility to adapt to change and eagerness to acquire new skills as necessary.

• Experience in medical and/or pharmaceutical fields; knowledge of medical terminology is beneficial.

• Bilingual proficiency in English and French is an asset.

• Strong analytical abilities.

• Effective oral and written communication skills.

• Strong interpersonal abilities.

• Excellent organizational skills and capacity to handle multiple tasks.

• Exceptional attention to detail.

• Ability to consistently meet deadlines.

• Outstanding problem-solving capabilities.

• Proficient in computer skills, including Microsoft Word, Excel, PowerPoint, and other Office applications.

• Reliable internet access is required for remote work.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Backup dependent care services.

• Adoption assistance programs.

• Infertility treatment coverage.

• Support for family building.

• Behavioral health solutions.

• Paid parental leave.

• Paid caregiver leave.

• Training programs.

• Resources for professional development.

• Mentorship programs.

• Employee resource groups.

• Opportunities for volunteer activities.

• Remote work options available.