Drug Safety Physician

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

Requirements:

  • Medical degree;
  • 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 Chinese (spoken and written) and in English (written);
  • Computer literacy.

 

申请这个职位