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 responsibilitiesPrimary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirementsPrompt and effective communication with local regulatory authoritiesProvision of local regulatory intelligence screening and expert adviceCollection and reporting of locally suspected ADRs or ICSRs (FUs, translations)Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issuesPreparation and collection of documentation for submissions to the regulatory authoritiesReview and linguistic input on local Product Information and Mock-ups  Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulationsPerform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety informationMaintain accurate records and documentation at local levelProvide support to the RA & PV Global operations teamEnsure compliance with MAH's and PrimeVigilance's proceduresSupport audits and InspectionsHandle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market
