长沙招聘

Be responsible for AE management both for PMS purpose and clinical trial including AE reporting to NMPA, working out reports such as the PRER requested by the NMPA or Avitum SOP, collecting and reporting oversea AE, communication with Headquater and the Competent Authority for related AE cases and etc.Work with the Sales/Marketing/Technical Service/BO team for complaint handling (collection, evaluation, reporting in global SAP C3 system, investigation as appropriate, following up and closure); complaint process improvement; NMPA follow up; trend analysis; communication with the oversea manufacturing sites or local supplier for complaint related issues.Be responsible for recall related activities including working out communication materials for recall, leading the cross-functional team to handle all recall related activities, on-site/desk audit to distributors/clinics, making sure all affected products are traced back and returned/destructed with evidence and working out reports as requested by the NMPA.Other tasks assigned by the quality manager, such as QMS related issues: internal audit, document destribution, training and Operation related issues: NC handling and etc..

任职要求：

1. BS degree or above in the following subjects: Medical Device, Pharmaceutics, Medicine, Chemistry, Biology and any other related subjects 2. Very good command of both spoken and written English 3. Very good command of MS office1. Min. 2+ QA experience in MD manufacturing industry is a MUST. 2. Comprehensive knowledge of GSP or GMP, AE reporting/evaluation, recall is required. 3. Experience in auditing is preferred. 4. Experience in commercial company is preferred.1. Excellent communication skills 2. Good problem identification and analysis skills

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