Pharmacovigilance Analyst

📋 Description

• Identify and assess AEs, ADRs, ADEs, and MDIs from source documentation
• Process ICSRs per SOPs including triage, data entry, MedDRA coding, narrative writing, and
• Manage expedited and periodic safety submissions per regulatory requirements
• Conduct literature reviews to identify safety information and ensure documentation
• Prepare/update safety reports (PSURs, PBRERs, PADERs, DSURs) and aggregate safety reports
• Perform signal detection and support risk management activities (RMPs/REMS)

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or equivalent experience
• At least 2 years in pharmacovigilance, regulatory affairs, QA, or related area
• Strong understanding of safety case processing and AE/ADR assessment
• Familiarity with ICSR management, MedDRA coding, medical evaluation, causality/seriousness, signal
• Ability to manage detailed safety data with SOPs and timelines
• Excellent written/verbal communication and collaboration skills

🎁 Benefits

• Salary: CAD $55,002–$109,901, depending on qualifications and experience
• Healthcare: Medical, dental, and vision benefits
• Well-being: Programs supporting physical, emotional, financial, and social wellness
• Family support: Dependent care, adoption assistance, parental leave, caregiver leave
• Professional development: Training programs and mentorship
• Community and inclusion: Employee resource groups and volunteering opportunities