Specialist, Local Regulatory and PV Network

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

📋 Description

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

• Act as the main local representative for Regulatory Affairs and Pharmacovigilance 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 lifecycle.

• Communicate swiftly and effectively with the MAH and local regulatory bodies.

• Function as the primary liaison with local regulatory authorities for Regulatory Affairs and Pharmacovigilance matters.

• Provide local regulatory intelligence screening and expert guidance for the designated regions.

• Gather and report locally suspected Adverse Drug Reactions (ADRs) or Individual Case Safety Reports (ICSRs), including follow-ups and translations.

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

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

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

• Keep precise local records and documentation.

• Provide support to the RA & PV Global operations team.

• Prepare and gather documentation for submissions to regulatory authorities.

• Review and offer linguistic insights on local Product Information and Mock-ups.

• Ensure compliance with MAH and PrimeVigilance protocols.

• Assist with audits and inspections.

• Manage local quality assurance responsibilities, including addressing 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' experience in pharmacovigilance or safety-related roles within a pharmaceutical, CRO, or regulatory context.

• Solid understanding of ICH Good Pharmacovigilance Practices (GVP) and local pharmacovigilance regulations (training or practical experience required).

• Preferred experience in case management, literature reviews, or local pharmacovigilance activities.

• Prior experience in Regulatory Affairs is advantageous, though not essential.

• Proficiency in English is required.

• Knowledge of additional languages is a plus.

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

🏝️ Benefits

• Option for remote work.

• Collaborative and supportive team environment.

• Flexibility, opportunities for growth, and a sense of belonging.

• Chance to collaborate with global teams.

• Opportunities for professional development.

• Work alongside a passionate and collaborative team of experts.

• Values-driven workplace committed to quality, integrity, ambition, adaptability, inclusivity, and collaborative partnerships.