Australia Licensed Pharmacovigilance Specialist

Job Summary

Acting as the primary local representative for Pharmacovigilance and Regulatory Affairs, the full-time Contractor will ensure compliance with national regulations in Australia, manage communication with regulatory authorities, and support the Marketing Authorisation Holder in maintaining product compliance throughout its lifecycle while working remotely.

Key responsibilities

• Manage communication with the Marketing Authorisation Holder and local regulatory authorities regarding Pharmacovigilance and Regulatory Affairs
• Oversee local management of risk minimization measures and ensure compliance with regulatory requirements
• Support the development and implementation of local pharmacovigilance systems in accordance with global standards

Required qualifications

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience
• At least 3 years of experience in pharmacovigilance or a safety-related role within the pharmaceutical or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements
• Experience in case handling or literature screening is preferred
• Proficiency in English; additional language skills are advantageous