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 a primary contact with local regulatory authorities, providing local regulatory intelligence and advice, and managing risk minimization measures. The role also involves preparing documentation for submissions, reviewing product information, and implementing a local pharmacovigilance system. They will perform literature screening for ADRs and maintain accurate records whilst supporting global operations, audits, and inspections.