Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - English & Spanish

The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle. Main responsibilities include being the primary contact person with local regulatory authorities, providing regulatory intelligence and advice, collecting and reporting ADRs, managing risk minimization measures, preparing documentation for submissions, reviewing product information, implementing the local pharmacovigilance system, performing literature screening, maintaining records, supporting global operations, ensuring compliance, handling QA tasks, and supporting audits and inspections.