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.