| Job Title: |
Drug Safety Specialist/Senior Drug Safety Specialist |
| Location: |
Shanghai |
Primary
The Drug Safety Specialist/Senior Drug Safety Specialist is responsible for the collection, processing, follow-up, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products in accordance with company standard operating procedures and applicable regulations.
Responsibilities
- Process individual case safety reports
- Perform proper coding in the safety database
- Produce concise and accurate case narratives
- Submit individual and periodical safety reports to the regulatory agencies
- Appropriately follow up AEs and SAEs
- Conduct AE/SAE reconciliation
- Perform literature searching and review
- Generate data listings from the safety database
Experience
- Required Skills and Knowledge:
- Attention to details
- Good knowledge of medical terminology
- Good written and communication skill
- Fluent in Chinese (spoken and written) and in English (written)
- Computer literacy
- Desired Skills:
- Experience in pharmaceutical safety-related role
- Previous Argus database experience
Requirements
- EDUCATION: Life science/Pharmacy/Nurse degree
- CONTACTS: Regulatory Affairs, Medical Affairs, Clinical Project Manager and other Safety Staff
If interested, please forward your resume to KellyL@hutch-med.com