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Clinical Operations and Regulatory Affairs, Shanghai | 30 Sep 2021

Drug Safety Specialist / Senior Drug Safety Specialist

Job Title: Drug Safety Specialist/Senior Drug Safety Specialist
Location: Shanghai

 

Primary

The Drug Safety Specialist/Senior Drug Safety Specialist is responsible for the collection, processing, follow-up, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products in accordance with company standard operating procedures and applicable regulations.
 

Responsibilities

  • Process individual case safety reports
  • Perform proper coding in the safety database
  • Produce concise and accurate case narratives
  • Submit individual and periodical safety reports to the regulatory agencies
  • Appropriately follow up AEs and SAEs
  • Conduct AE/SAE reconciliation
  • Perform literature searching and review
  • Generate data listings from the safety database

 

Experience

  • Required Skills and Knowledge:
    • Attention to details
    • Good knowledge of medical terminology
    • Good written and communication skill
    • Fluent in Chinese (spoken and written) and in English (written)
    • Computer literacy
  • Desired Skills:
    • Experience in pharmaceutical safety-related role
    • Previous Argus database experience

 

Requirements

  • EDUCATION: Life science/Pharmacy/Nurse degree
  • CONTACTS: Regulatory Affairs, Medical Affairs, Clinical Project Manager and other Safety Staff

 
If interested, please forward your resume to KellyL@hutch-med.com