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. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

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