莆田招聘

合同：与中智合同签订一年，长期职位

工作内容

? Support China AE report process

Maintain license information in China government ADR system

Maintain related information, license, distribution, in Shanghai MD traceability system

Check the customer (Hospital) AE reporting in China government ADR system daily

Input the Hospital reporting to global complaint system and local CPMS system

Make oversea AE decision according China regulation and global requirements ( timeline)

Report oversea AE to China government ADR system

Coordinate China PRER process (Periodical Risk Evaluation Report) to ensure regulation compliance

? Chinese labeling system (CLS)

Create and maintain license information in CLS

Maintain Chinese instruction for use (IFU) in CLS

Check the Chinese IFU made by vendor

Communicate with warehouse, RA to ensure label information correct

Release final Chinese IFU to warehouse and vendor

? Maintain quality & regulatory compliance records on a daily basis

Update license, IFU and related CLS communication records to shared folder

应聘条件

Bachelor’s degree or above, preferably a graduate from University/College (major in medical device, pharmaceuticals, medicine, mechanical, or relative)

Good interpersonal & communication skills;

Strong team work spirit

Fluent spoken and written English, facilitating business communication

上海中智项目外包咨询服务有限公司是中智上海全资子公司，发展至今，经与几千家各个行业的企业成功合作，服务网络覆盖全国300多个城市。以服务外包的形式为企业提供“优质、高效、便捷”的灵活用工、项目管理、办公室商务服务等，其中全球500强企业占比超过50%，涉及制造、金融、化工、医药、奢侈品与消费品、进出口贸易等行业，并且与服务客户建立了良好的合作伙伴关系。
中智将以不懈追求卓越的精神，坚持传承与创新，积极探索企业发展的新方向、新路径，推动企业实现新发展，继续强化质量意识，加强质量管理，落实质量责任，提高服务质量，进而为将上海建设成“具有国际竞争力的质量高地”作出更大的贡献。