Our client, a pharmaceutical company is looking for a high calibre candidate to fulfil the above-mentioned position. Details are as followings:
· To handles self-inspection of QA
· To represents company to participate the CSPV activities, ie. LSO TC
· meeting, CSPV training, etc
· To handles the assigned PV activities, to be the primary contact person with Syneos Health on the AE/ADR reporting, literature search, monthly reconciliation to partners, etc
· To Follow-up data collection of AE/ADR/specified questionnaires/special situations with MRs/AZHK/partners
· To handles signal detection and report to line manager/DSJ-CSPV
· To provides PV training to partners, RMP/safety related training to diff. BU members
· To updates PV/RMP training materials based on the DS policy, local regulations and product-related updates
· To maintains patient safety system based on DS policy and local regulation, establishes new SOPs if necessary
Undergraduate in Pharmaceutical or Sciences or related discipline
· At least 2 years of QA / PV experience
· Proficient in MS Office application (Excel, Word & PowerPoint)
· Fluent written and spoken English and Chinese with good communication and presentation skills
· Well organized, self-motivated, and Work independent
· 5 days work
· Annual leave
· Medical scheme
· MNC company
· Working location: Causeway Bay,
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