Local Contact Person – Pharmacovigilance and Regulatory Affairs

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Serve as the Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA).

• Act as the primary local representative for RA&PV to ensure adherence to national pharmacovigilance and regulatory standards in Australia.

• Implement local pharmacovigilance and regulatory affairs initiatives.

• Assist the Marketing Authorisation Holder in upholding product compliance throughout its entire lifecycle.

• Communicate effectively and promptly with the Marketing Authorisation Holder and local regulatory bodies.

• Act as the main liaison with local regulatory authorities for Regulatory Affairs and Pharmacovigilance.

• Provide local regulatory intelligence screening and expert guidance.

• Gather and report locally suspected ADRs or ICSRs.

• Oversee or manage risk minimization strategies related to urgent safety restrictions and emerging safety concerns.

• Aid in the development and execution of the local pharmacovigilance system.

• Conduct local non-indexed literature reviews and monitor regulatory authority websites for ADRs and safety data.

• Maintain precise local records and documentation.

• Support the RA & PV Global Operations team.

• Prepare and gather documentation for submissions to regulatory authorities.

• Review and provide linguistic feedback on local Product Information and mock-ups.

• Ensure compliance with MAH and PrimeVigilance procedures.

• Assist with audits and inspections.

• Manage local QA responsibilities, including issues related to suspected counterfeit products and quality alerts from health authorities.

⛳️ Requirements

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience.

• Minimum of 3 years of experience in pharmacovigilance or safety-related roles within pharmaceutical, CRO, or regulatory settings.

• Solid understanding of ICH GVP and local pharmacovigilance regulations (either through training or practical experience).

• Preferred experience in case handling, literature review, or local pharmacovigilance activities.

• Previous experience in Regulatory Affairs is desirable but not essential.

• Proficiency in English is required.

• Knowledge of additional languages is a plus.

• Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint.

🏝️ Benefits

• Availability of remote work options.

• Collaborative and supportive team atmosphere.

• Flexible work culture.

• Opportunities for growth and professional development.

• Chance to contribute to patient safety and global pharmaceutical initiatives.