Ashley Lin

Experience

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  Taipei Veterans General Hospital

  Dec 2008 - Dec 2009

  Hospital pharmacist

  •Clinical pharmacotherapy•Report adverse drug reaction cases•Dispensing prescription drugs•Pharmaceutical consultation

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  Taiwan Drug Relief Foundation

  Aug 2010 - Mar 2015

  Drug safety associate

  •Collect nationwide adverse drug reactions from pharmaceutical companies, hospitals and pharmacies ; help Taiwan FDA maintain the e-based ADR system.•Review adverse drug reaction reports with causality assessment.•Identify important drug safety issues, collect relative information(data) and give suggesting reports for Taiwan FDA safety advisory committee so as to make executive decision.•Provide seminars for health care institutions and pharmaceutical companies on the topic of post-market surveillance in Taiwan. Show less

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  UCB

  Mar 2015 - now

  Implement and maintain a pharmacovigilance system for the UCB products authorized in SEA and ensure compliance with regulatory requirements;Maintain thorough knowledge of the national current pharmacovigilance regulatory requirements;Ensure communication of national pharmacovigilance requirements to global Patient Safety;Ensure that all information relevant to the benefit/risk balance of the UCB products is reported to Patient Safety (including the EEA QPPV for products authorized in the EEA) for further review and to the competent authorities according to the local pharmacovigilance legislation;Work in close collaboration with global Patient Safety teams in order to ensure that local obligations are managed and compliance to local authorities is maintained;Establish and maintain the quality management system related to the pharmacovigilance system at the affiliate level;Maintain local pharmacovigilance SOPs/AI to describe local processes and requirements;Maintain a functional connection with the EU QPPV, e.g. participating in regular LSOs meetings organized by global Patient Safety;Interface with key affiliate stakeholders and departments in the local UCB office to ensure that pharmacovigilance requirements are implemented;Establish and maintain local Safety Data Exchange Agreements (SDEA), ensuring updates are provided to Patient Safety (Safety Agreements team). Ensure oversight of global SDEA which apply in the territories under ASO responsibility;Participate pharmacovigilance audits/inspections, ensuring timely identification and implementation of respective CAPAs;Ensure inspections/audit readiness of the relevant local departments in full collaboration with Patient Safety and Quality Assurance;Ensure that a pharmacovigilance training (obligation to immediately report any relevant safety information) is provided to any local UCB employee/contractor/agent of territories under ASO responsibility, including sales representatives. Show less

  • Taiwan and Hong Kong Safety Leader & Deputy Local Safety Officer for India

    Nov 2022 - now

  • South-east Asia Patient Safety and Medical Information Leader & Deputy LSO for India

    Nov 2021 - Nov 2022

  • Patient Safety and MedInfo Leader Taiwan, Hong Kong, South-East Asia

    Nov 2018 - Nov 2021

  • Deputy Patient Safety and MedInfo Leader Taiwan, Hong Kong, South-East Asia

    Aug 2018 - Nov 2018

  • Deputy Area Safety Officer for South-East Asia

    Mar 2015 - Aug 2018