Pharmacovigilance Analyst

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

📋 Description

• Identify information related to Adverse Events (AE), Adverse Drug Reactions (ADR), Adverse Drug Experiences (ADE), and Medical Device Incidents (MDI) from source documents.

• Process Individual Case Safety Reports (ICSRs), encompassing triage, duplicate searches, data entry, MedDRA coding, narrative writing, medical evaluation, seriousness, expectedness, causality, reportability, and both expedited and periodic submissions.

• Conduct literature reviews in accordance with relevant SOPs and work instructions.

• Prepare and/or review aggregate reports, which include ASRs, IRSRs, PSURs, PBRERs, PADERs, and DSURs.

• Execute signal detection activities.

• Prepare and/or update Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and related documentation.

• Serve as a point of contact for clients.

• Collaborate with internal and external stakeholders to obtain additional information or clarification.

• Support audit preparation efforts.

• Organize and maintain documents in accordance with applicable SOPs and work instructions.

• Undertake additional tasks as assigned by the Manager.

• Availability for standby/on-call duties may be necessary.

⛳️ Requirements

• A Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a similar discipline, or equivalent experience is required.

• A minimum of 2 years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field is required.

• Certification in regulatory affairs, quality management, compliance, or auditing is preferred.

• Availability for standby/on-call duties may be necessary.

🏝️ 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 activities.

• Reasonable accommodations during the employment process.