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. 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, collecting and reporting ADRs, managing risk minimization measures, preparing documentation for submissions, reviewing product information, and implementing a local pharmacovigilance system. Additional responsibilities include performing literature screening, maintaining accurate records, supporting the Global operations team, ensuring compliance with procedures, and handling local QA tasks.