Pharmacovigilance & Medical Information Specialist

Xediton Pharmaceuticals Inc.; Oakville; Presencial; CAD 65.000 - 70.000; Jornada completa

Descripción de la vacante

Xediton Pharmaceuticals Inc. is seeking a Pharmacovigilance and Medical Information Associate to support the Medical & Scientific Affairs team in Oakville, Ontario.

You will contribute to safety, regulatory, and medical information activities, ensuring accuracy and compliance across the product lifecycle. Responsibilities include evaluating safety data, preparing adverse event reports for Health Canada, conducting causality assessments, literature reviews, and supporting PV inspections and

Formación

• University degree with PV experience
• Knowledge of Canadian regulatory requirements (Food & Drug Act & Regulations)
• Knowledge of Canadian GMPs and Pharmacovigilance
• Solid working knowledge of Pharmacovigilance
• Excellent written and oral communication skills
• Independent worker with strong time-management under pressure

Responsabilidades

• Triage and evaluate ICRS for validity, seriousness and reportability
• Prepare and submit adverse event reports (CIOMS) to Health Canada per PV agreement
• Conduct causality assessments for safety cases and liaise with Global safety
• MedDRA coding assessment
• Evaluate PV reports and maintain PV system
• Literature screening for adverse events and summarize evidence
• Prepare for PV inspections and audits and implement corrective actions
• Generate responses to regulatory requests on product safety issues

Conocimientos

Excellent communication

Organizational skills

Self-starter

PV system knowledge

Proficient computer skills

Educación

University Science Degree

Herramientas

Microsoft Office

Descripción del empleo

Xediton Pharmaceuticals Inc. is seeking a Pharmacovigilance and Medical Information Associate to support the Medical & Scientific Affairs team in Oakville, Ontario.

You will contribute to safety, regulatory, and medical information activities, ensuring accuracy and compliance across the product lifecycle. Responsibilities include evaluating safety data, preparing adverse event reports for Health Canada, conducting causality assessments, literature reviews, and supporting PV inspections and