Drug Safety Physician

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The Drug Safety Physician is responsible for monitoring and management of safety profile for the assigned projects and drugs.

RESPONSIBILITIES  :

  • Proactively review and evaluate the clinical implications of safety data from different sources for assigned projects.
  • Conduct signal detection and evaluation for assigned projects.
  • Review and input on protocols, IBs and all safety sections of clinical and/or regulatory submission documents.
  • Draft, review Periodic Safety Report (e.g., DSUR and PSUR).
  • Draft, review the safety part of Investigator Brochure.
  • Draft SUSAR notification letter.
  • Provide responsible development projects with safety input and support.
  • Implement other safety responsibilities assigned by LM.

Qualification

Required Skills and Knowledge :

  • Minimum 3 years of Drug Development/Drug Safety experience.
  • Good knowledge of medical terminology.
  • Good written and communication skill.
  • Working knowledge of MedDRA and WHODrug dictionary.
  • In-depth knowledge in drug safety regulations and policies.
  • Fluent in both Chinese and in English.
  • Computer literacy.

Desired Skills :

  • Experience in pharmaceutical safety-related role.

Requirements :

EDUCATION :

  • Medical degree.

CONTACTS  :

  • Regulatory Affairs, Medical Affairs, Clinical Project Manager and other Safety Staff.

SUPERVISOR RESPONSIBILITY :

  • None.