Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA)

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 in the United States. 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 with local regulatory authorities, providing local regulatory intelligence, collecting and reporting ADRs or ICSRs, managing risk minimization measures, preparing documentation for submissions, reviewing product information and mock-ups, and developing local pharmacovigilance systems. The role also involves performing literature screening, maintaining records, supporting global teams, ensuring compliance, assisting with audits, and handling local QA tasks.