- Case processing of solicited adverse event reports (case data entry, MedDRA coding, drafting
initial narratives) including review of related documents and follow-up
- Regulatory reporting of individual case safety report(ICSR)/aggregate reports and other safety issues
- Monitor incoming cases and queries in PV mailbox
- Review medical literature and all source of information to update company knowledge with regards to
drug safety
- Establishing/maintaining SOP¡¯s processes, practice and guidelines
- Outsourced PV works management
- Archiving safety documents
Áö¿øÀÚ°Ý
- Possess up-to-date knowledge of PV regulations
- Experience in a pharmaceutical or biotechnology company (as a PV or CT staff)
- Bio ÀǾàÇ° Çã°¡ °æÇèÀÚ
- Good Command of English
- ¾àÇÐ,°£È£ÇÐ ¹× °ü·ÃÇаú