Drug Safety Specialist / Senior Specialist

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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.

Qualification

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.

SUPERVISOR RESPONSIBILITY  :

  • None.