The Drug Safety Physician/Scientist 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
EXPERIENCE
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 Chinese (spoken and written) and in English (written)
？ 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.