Drug Safety Associate

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

📋 Description

• Receive, scan, and document essential clinical information in accordance with SOP/protocol and relevant legislation.

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

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

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

• Enter 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 as per established work instructions.

• Assist with or perform source data verification checks as required.

• Review medical and scientific literature for relevant safety information.

• Generate reconciliation reports on a weekly, monthly, and other scheduled basis.

• Execute transcription, translation, and redaction tasks as needed.

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

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

• Undertake other duties and tasks as assigned.

⛳️ Requirements

• Minimum college-level education is required.

• A diploma or degree with a concentration in Life Sciences is highly desirable.

• 1-3 years of experience in Medical Information, Clinical Research, or Drug Safety, or equivalent experience in pharmacy or pharmaceutical fields.

• Familiarity with the Pharmacovigilance industry is essential.

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

• Ability to adapt to change and acquire new skills as necessary.

• Experience in the medical and/or pharmaceutical sectors; knowledge of medical terminology is advantageous.

• Bilingual proficiency in English and French is beneficial.

• Strong analytical capabilities are required.

• Excellent communication skills, both verbal and written.

• Strong interpersonal abilities.

• Effective organizational skills and capacity to manage multiple tasks.

• Exceptional attention to detail.

• Proven ability to consistently meet deadlines.

• Strong problem-solving skills with the ability to effectively communicate and resolve issues.

• Proficiency in computer skills, including Microsoft Word, Excel, PowerPoint, and other Office Programs.

• Reliable internet connection is required for remote work.

🏝️ Benefits

• Medical, dental, and vision care coverage.

• Backup dependent care services.

• Adoption assistance available.

• Infertility treatment coverage.

• Family building support offered.

• Access to behavioral health solutions.

• Paid parental leave provisions.

• Paid caregiver leave options.

• Opportunities for training programs.

• Resources for professional development.

• Participation in mentorship programs.

• Employee resource groups available.

• Engagement in volunteer activities.

• Option for remote work arrangements.

• Reliable internet connection is necessary for remote work.