Pharmacovigilance and Medical Information Associate

Company Description:

Xediton is a specialty pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. We are located in Oakville, Ontario.

Pharmacovigilance and Medical Information Associate

Job Description & Key responsibilities:

The Pharmacovigilance Associate will provide service to both external customers and also support internal management.

Specific responsibilities include:

·        Triage and evaluate ICSRs for validity, seriousness and reportability.

·        Prepare and submit adverse event reports (CIOMS) to partner and Health Canada as per Pharmacovigilance agreement in a timely manner  

·        Conduct causality assessments for safety cases reports and liaise with Global safety officer and partners for improvement in product safety.

·        MedDRA coding assessment

·        Evaluate pharmacovigilan...