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.
- 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.
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.
- Life science/Pharmacy/Nurse degree.
- Regulatory Affairs, Medical Affairs, Clinical Project Manager and other Safety Staff.
SUPERVISOR RESPONSIBILITY ：