长沙招聘

1. Ensure collection and reporting of product safety information from various sources, e.g., spontaneously from HCP and consumers, literatures, product complaint, social media, regulatory authorities, solicited sources such as post-marketing studies, patient support/assistant programs, market researches, etc. in good quality and in compliance with governing laws and legislations.

2. Ensure on time preparation and submission of aggregated safety reports, e.g., PSUR/PBERE, annual report.

3. Support in signal management and risk management.

4. Support safety agreement management and coordinate safety data exchange with license partners.

5. Manage PV service providers.

6. Interact with concerned Regulatory Authorities, e.g., safety enquiries, etc.

7. Collaborate with other functions, e.g. with RA, QA, commercial, etc.

8. Collaborate with counterparties from Kite/Gilead and Fosun Pharma.

9. Support PV quality system management, e.g., create and maintain PV SOP/WI/Guidance, deliver PV trainings to internal and external stakeholders, ensure audit and inspection readiness.

10. Complete other assigned work as one of clinical team.

任职要求：

1. Bachelor degree or above, medicine is preferred.
2. At least 2 years PV experience, oncology/haematology area is preferred.
3. With ICH-GCP/GCP training.
4. Familiar with regulatory requirements on PV.
5. With good English skills (oral and writing).
6. With good communication skill and team spirit.
7. With good computer skills.

关于复星凯特生物科技有限公司
复星凯特生物科技有限公司为上海复星医药集团与美国 Kite Pharma（吉利德旗下公司）的合营企业， 2017年 4月于中国上海注册成立。立足于自主研发和技术转移相结合，复星凯特致力于肿瘤免疫细胞治疗技的产业化和规范化，造福中国患者。

About Fosun Kite Biotechnology Co., Ltd.
As a joint venture of Shanghai Fosun Pharmaceutical (Group) Co., Ltd and U.S. Kite Pharma, Fosun Kite Biotechnology Co., Ltd. (hereinafter referred as "Fosun Kite") was established in April 2017 in Shanghai China. Taking a combined approach of internal R&D and external partnering/technology transfer, Fosun Kite is dedicated to the advancement of innovative cell therapy and its industrialization in China to benefit patients.