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 pharmacovigilance and regulatory requirements in Australia while managing communications with the Marketing Authorisation Holder and local regulatory authorities.

Key responsibilities

• Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
• Manage local regulatory intelligence and oversee risk minimization measures related to safety issues
• Support the development and implementation of local pharmacovigilance systems in compliance with global standards

Required qualifications

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience
• At least 3 years of pharmacovigilance or safety-related experience in a pharmaceutical, CRO, or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements
• Experience in case handling, literature screening, or local PV activities is preferred
• Proficiency in English, with additional language knowledge being advantageous