Local Regulatory and PV Specialist

Job Summary

Acting as the Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs, the full-time Local Regulatory and PV Specialist will ensure compliance with national pharmacovigilance and regulatory requirements in Australia while supporting the Marketing Authorisation Holder in maintaining product compliance throughout its lifecycle, with the opportunity to work remotely.

Key responsibilities

• Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
• Provide local regulatory intelligence and expert advice while managing risk minimization measures related to safety issues
• Support the development and implementation of local pharmacovigilance systems in compliance with global standards and local regulations

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 or local PV activities is preferred
• Proficiency in English and strong skills in Microsoft Office applications