About this role
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.