職位描述
負(fù)責(zé)中國(guó)區(qū)域產(chǎn)品的投訴處理，在Trackwise系統(tǒng)中建立投訴信息；同時(shí)關(guān)注產(chǎn)品投訴的趨勢(shì)及可能引起的產(chǎn)品質(zhì)量問(wèn)題，嚴(yán)格遵照GQS130要求處理產(chǎn)品投訴。密切配合APRC的投訴調(diào)查工作。
To be the RCP of China Affiliate and perform product complaints in China, and create the related complaint records in Trackwise System; Monitor incoming product complaint trends an incidents that may relate to a quality issue with product. Strictly follow up the GQS130 product complaint requirement. Work closely with APRC to handle complaint activities.
跟蹤投訴產(chǎn)品的返回及寄送，保證樣品調(diào)查在規(guī)定45天完成。
Follow up complaint sample return and delivery to APRC or manufacturer/packaging site for further investigation and to ensure closed within 45calendays as required.
負(fù)責(zé)協(xié)調(diào)所有與安全相關(guān)的不良反應(yīng)/產(chǎn)品投訴的培訓(xùn)。
Coordinate AE/PC training for all Lilly persons cooperating with Safety
及時(shí)進(jìn)行季度和年度產(chǎn)品投訴回顧。
Timely complete product complaint trend analysis report quarterly and yearly.
負(fù)責(zé)與病人安全及 禮來(lái)中國(guó)服務(wù)熱線進(jìn)行AE/PC的衡算。
Be responsible for the reconciliation of AE/PC with Patient Safety and PSP hotline and LCAC.
負(fù)責(zé)完善相應(yīng)的產(chǎn)品投訴SOP
To be responsible for complaint SOP updates
*進(jìn)口產(chǎn)品放行的候選
Back up for batch release of imported product.
主管安排的工作
Other tasks assigned by Supervisor.
基本資格要求
本科及以上學(xué)歷，藥學(xué)，化學(xué)或相關(guān)專業(yè)
Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences
至少1年的藥品質(zhì)量管理QA經(jīng)驗(yàn)和投訴處理經(jīng)驗(yàn)
At least three years of QA experience in drug product distribution/ wholesaler and complaint handling practices.
能用英語(yǔ)聽(tīng)，說(shuō)和寫(xiě)
Capable of listening, speaking and writing in English in fluency
