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.