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.