QPPV Professsional

Role Summary This is a highly specialized professional focused on Taiwan post marketing PV and serving as the primary liaison with local regulatory authorities. As the same time, a portion of this role is dedicated to supporting clinical PV activities in Taiwan. Key Activities - Regulatory Compliance and Local Representation • Serve as the main pharmacovigilance contact for the local Health Authority. • Set-up local PV system as applicable, including the preparation of local business operation procedures as relevant. Ensure full compliance with national pharmacovigilance legislation and global regulatory requirements. • Participate in and/or co-host local Health Authority inspections and audits as applicable. • Create and implement local PV business continuity activities (including appointment of deputy LPPV or back up as applicable). • Perform local regulatory intelligence that might have impact on PV activities, assess the impact of any change(s) and communicate timely to QPPV Office and other relevant stakeholders as applicable. • Support translation of documentation to local language and submissions to local authorities as applicable. • Ensure local PV processes follow the EU GDPR and inform QPPV Office about specific local requirements related to GDPR. • If required, act as Locally Nominated Person Responsible for Pharmacovigilance towards the local Health Authority (HA) and perform relevant activities as per local regulation. - Adverse Event Management • Ensure reporting of any ICSRs to global safety mailbox if these are received locally. • Assist with follow-up for ICSRs in local language when required. - Risk Management and Safety Communication • Act as local Subject Matter Expert (SME) for local Risk Management activities. • Support the preparation of local Risk Management Plans and provide relevant local specific data for inclusion in local RMP, as applicable. • Ensure local implementation of Risk Management Plans (RMPs) and additional risk minimization measures (aRMMs). • Monitor and report on local effectiveness of risk minimization activities. • Review and approve locally adapted safety communication materials, including Direct Healthcare Professional Communications (DHPCs). - Literature Monitoring • Ensure local literature surveillance (including search strategy) is set up. • Ensure that local literature surveillance is performed, including the reporting of relevant safety signals and ICSRs from local sources to global safety teams as applicable. Qualifications - Solid PV experience and knowledge of local PV day to day operations. - Proven experience interacting with sponsors, regulatory authorities. - Good English communication and teamwork. Learn more about our EEO & Accommodations request here .