담당업무

1) Ensure that systems and processes are available for collection and reporting of safety information to meet local and global requirements

2) Maintain oversight on day-to-day AE inbound and outbound reporting as applicable

3) Oversee data generating activities to ensure appropriate review and reporting process are included in project documents for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites),

4) Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level.

5) Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holders (MAH).

자격요건

-  5~ 12 years of experience in PV/Medical safety related field essential; experience working in the pharmaceutical industry is strongly preferred

- Pharmacist license is must

- Experience in conducting training

- Knowledge of PV regulations

- Experience using global safety database desirable

- Demonstrated attention to detail

- Excellent written and spoken communication and presentation skills