Safety Lead

📋 Description

• Lead and oversee safety activities across clinical projects, including kickoffs, study meetings
• Develop and review project safety management, reporting, and medical coding plans.
• Oversee SAE and SUSAR case management from intake through regulatory reporting.
• Partner with sponsors, vendors, study teams, and internal stakeholders to design safety tools
• Participate in safety databases setup and oversee safety data capture, review, and reporting.
• Conduct QC of safety documents, reports, training materials, and pharmacovigilance deliverables.

🎯 Requirements

• Bachelor’s degree in a relevant field with a healthcare professional background.
• 10+ years of clinical safety experience and at least 5 years in pharmacovigilance.
• Hands-on experience with global safety databases, SAE processing, and safety report generation.
• Strong knowledge of MedDRA, WHODrug, FDA safety regulations, ICH guidelines, and global regulatory
• Understanding of clinical trial safety reporting and pharmacovigilance across regulatory
• Experience supporting internal audits, inspection readiness, and regulatory inspections in clinical

🎁 Benefits

• Fully remote opportunity based in Canada.
• Senior-level position with significant responsibility across clinical safety and pharmacovigilance
• Opportunity to serve as a safety subject matter expert and influence standards/processes.
• Exposure to global clinical development programs, sponsors, vendors, and regulatory environments.
• Mentoring Safety Specialists and contributing to professional/departmental development.
• Involvement in strategic initiatives, client engagements, audits, inspections, and complex safety