Pharmacovigilance Regulatory Affairs Specialist

Job Summary

A company is looking for a Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & French.

Key Responsibilities

• Act as the primary contact with local regulatory authorities for Pharmacovigilance and Regulatory Affairs
• Manage local reporting of adverse drug reactions and oversee risk minimization measures
• Prepare documentation for regulatory submissions and ensure compliance with local regulations

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/or relevant educational background as required by local regulations
• Expert knowledge of ICH GVP and local regulatory requirements