南京招聘

PRINCIPAL RESPONSIBILITIES:

1. Collection, translation, quality check and reporting of individual case safety reports (ICSRs) to headquarter. The source of ICSR include spontaneous, clinical trials, China Competent Authorities and all other potential sources.

2. Submit ICSR, if applicable to China Health Authority (HA) in required time and format.

3.Ensure accurate and consistent transcription, translations of all PV information from source documents with emphasis on timeliness and quality.

4. Ensure awareness of regulation updates which may have an impact on PV activities.

5. Ensure compliance with global and local PV procedural documents and local regulation.

6.Perform case follow-ups as needed. And handle FU information properly according to procedure documents.

7.Detect and report ADRs from Local Scientific Literatures.

8.Report Foreign SADRs to China HA in compliance with China regulations.

9.Submit aggregate reports (eg, PSUR, DSUR) to China HA in compliance with China regulations.

10.Perform monthly reconciliation with related stakeholders, as required in procedure documents.

11.Timely tracking and archiving of PV related documents including: receipts, processing, reporting and follow-up of all PV reports.

12. Ensure proper documented training on PV responsibilities required by regulation, global procedures or local procedures.

EDUCATION & EXPERIENCE REQUIREMENTS: 

1.Bachelor degree in clinical medicine, pharmacy or similar background.

2.Experiences in PV area at least 2 year, multinational pharmaceutical industry is preferred.

3. Knowledge of PV concept and China regulations.

4.Fluent in both written and spoken English

5.Good computer skill in Word, PowerPoint, and Excel.

6.Good problem solving and decision making skill.

7.Opening, optimistic and easy going personality.

吉瑞大药厂总部位于匈牙利布达佩斯，是一家以创新和研发为导向的、从原料到成品纵向一体化的制药企业。成立于 1901的吉瑞大药厂经过百年发展，已成长为年销售额达10多亿美元的大型跨国企业，凭借自身的营销网络将产品推广 至全球100多个国家，聘用员工11000余名。吉瑞大药厂是妇科领域的市场领导者之一，拥有覆盖***各年龄阶段的产品及创新的产品线。

吉瑞全球官网 – www.richter.hu
Gedeon Richter is a vertically integrated, innovative, research and development driven speciality pharmaceutical company headquartered in Budapest, Hungary. Founded in 1901 Gedeon Richter has grown to a billion-dollar multinational group of companies, distributing products in more than 100 countries through its own marketing network , employing more than 11.000 people worldwide. Gedeon Richter is a marketleader in the field of gynecology with a comprehensive product portfolio and innovative pipeline products.

Gedeon Richter Global website – www.richter.hu
吉瑞中国是一家致力于吉瑞大药厂开发的处方药、非处方药以及其他相关生命健康领域的产品在中国进行市场调研、临床数据采集和分析、学术推广、新产品展览展示、市场试推广等服务的公司。吉瑞中国将进一步巩固和加强现有或未来的处方药、非处方药及第三方产品在中国市场的地位。作为行业领导者，我们为您的产品在中国市场的成功提供一切必需的，有效的服务。
Gedeon Richter China is a majority stake JV of Gedeon Richter with Rxmidas Pharmaceuticals in China. Gedeon Richter China achieved sales of 64 mio USD in 2013. We will continue to strengthen and grow the market position for all our existing and future Rx and OTC products as well as for all licensed-in third party products in China. We cover both the Rx and OTC market with separate sales-force and integrated services under the Gedeon Richter China and GRmidas brand franchises. As a leading service provider in China, we offer in house all services necessary for your products to be successful in China.