Experience

Genor BioPharma Co., Ltd.

• China
• Biotechnology Research
• 1 - 100 Employee

• Pharmacovigilance Senior Director PV head

  • Nov 2020 - Present



AstraZeneca GMD

• GMD Oncology TA safety physician-Associate Director

  • Mar 2019 - Nov 2020

  Key job responsibilities: Safety governance and Risk Management actives Key job responsibilities: Safety governance and Risk Management actives



betapharma shanghai co., ltd.

• Chemical Manufacturing
• 1 - 100 Employee

• Pharmacovigilance Director

  • Apr 2018 - Mar 2019



Innovent Biologics

• China
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Pharmacovigilance Associate Director

  • Jan 2017 - Feb 2018



Jiangsu Hengrui Pharmaceuticals Co., Ltd.

• China
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• PV head

  • Feb 2016 - Jan 2017



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Safety physician

  • Aug 2015 - Feb 2016



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Supervisor, Product Safety Surveillance and Reporting

  • Apr 2006 - Aug 2015

  Key job responsibilities: • Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. • Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately. • Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labelledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly. • Review case criteria to determine the appropriate workflow for case processing. • Write and edit the case narrative. • Generate reports, ensuring adherence to regulatory compliance timelines. • Determine and perform appropriate case follow-up, generating and requesting follow-up letters. • Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation. • Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database. • Consistently apply regulatory requirements and Pfizer policies. Show less