Specialist, Local Regulatory and PV Network
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Job Description
Local pharmacovigilance and regulatory specialist managing Argentina-based safety and regulatory activities. Supporting pharmaceutical compliance, authority submissions, ADR reporting and patient safety.
Responsibilities:
- 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 MAH and local regulatory authorities
- Act as primary contact with local regulatory authorities for Regulatory Affairs and Pharmacovigilance
- Provide local regulatory intelligence screening and expert advice for responsible regions
- Collect and report locally suspected ADRs or ICSRs, including follow-ups and translations
- 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 potential 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 quality assurance tasks, including suspected falsified products and quality alerts from health authorities
Requirements:
- 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
Benefits:
- Remote work available
- Collaborative and supportive team culture
- Flexibility, growth and belonging
- Opportunity to work with global teams
- Professional growth opportunities
- Passionate and collaborative team of experts
- Values-driven workplace focused on quality, integrity, drive, agility, belonging and collaborative partnerships
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