The Drug Safety Physician is responsible for monitoring and management of safety profile for the assigned projects and drugs.
- 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.
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.
- Medical degree.
- Regulatory Affairs, Medical Affairs, Clinical Project Manager and other Safety Staff.
SUPERVISOR RESPONSIBILITY ：