Pharmacovigilance Regulatory Affairs Specialist

Job Summary

A company is looking for a Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) who is fluent in English and French, and can work from home anywhere in Canada.

Key Responsibilities

• Act as the primary contact with local regulatory authorities for Pharmacovigilance and Regulatory Affairs
• Manage the collection and reporting of adverse drug reactions and ensure compliance with local regulations
• Prepare documentation for submissions to regulatory authorities and support audits and inspections

Required Qualifications

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent experience
• Minimum 3 years of experience in the pharmaceutical or CRO industry or regulatory authority
• At least 2 years of experience in a LCPPV role or relevant pharmacovigilance position
• Pharmacovigilance training and knowledge of ICH GVP and local regulations
• Proficiency in English and French, both written and verbal