Local Contact Person – Pharmacovigilance and Regulatory Affairs

• Act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA)
• Serve as the primary local RA&PV representative to ensure compliance with national pharmacovigilance and regulatory requirements in Australia
• Execute local pharmacovigilance and regulatory affairs activities
• Support the Marketing Authorisation Holder in maintaining product compliance throughout its lifecycle
• Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
• Serve as primary contact with local regulatory authorities for Regulatory Affairs and Pharmacovigilance
• Provide local regulatory intelligence screening and expert advice
• Collect and report locally suspected ADRs or ICSRs
• Manage or oversee risk minimization measures related to urgent safety restrictions and emerging safety issues
• Support development and implementation of the local pharmacovigilance system
• Perform local non-indexed literature screening and regulatory authority website screening for ADRs and safety information
• Maintain accurate local records and documentation
• Support the RA & PV Global Operations team
• Prepare and collect documentation for regulatory authority submissions
• Review and provide linguistic input on local Product Information and mock-ups
• Ensure compliance with MAH and PrimeVigilance procedures
• Support audits and inspections
• Handle local QA tasks, including suspected falsified products and quality alerts from health authorities

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
• At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
• Experience in case handling, literature screening, or local PV activities is preferred
• Prior experience in Regulatory Affairs is preferred but not mandatory
• Proficiency in English
• Additional language knowledge is advantageous
• Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

• Remote work available
• Collaborative and supportive team environment
• Flexible work culture
• Growth and professional development opportunities
• Opportunity to contribute to patient safety and global pharmaceutical projects