南平招聘

ob Description:

· Perform daily AE case reporting to GPV&E and SFDA.

· Ensures pharmacovigilance (PV) compliance with all appropriate GPV&E and BMS corporate SOPs, procedures and regulatory reporting requirements for the country for licensed and clinical trial products.

· Contributes actively to the development and implementation of global GPV&E SOPs, as required. Ensures adherence to the relevant global and local GPV&E SOPs and legislation.

· Builds effective working relationships to ensure that the PV function is integrated effectively into the local Country Medical Department e.g. works effectively with Director of Medical Science Managers (MSMs), RCO .

· Interfaces with other internal local functional departments, such as Regulatory, Sales and Legal, to ensure all local safety issues are dealt with effectively. Develops an excellent working relationship with the local Regulatory Authority

· Contribute the planning, preparation, co-ordination, conduct and response to internal audits and external PV regulatory inspections, in collaboration with GQRC, QST and/or QP Office.

· Ensures timely and quality responses to safety enquiries from Health Care Professionals, Regulatory Authorities and ethics committees; enquiries from Medical Information will be reconciled with the Global Safety Database; all responses will be filed.



Minimum requirements:

1. University degree or above in medicine/pharm related major; Medical background is preferred

2. More than 1 year Pharmacovigilance related working experience in MNC

3. Good understanding of PV regulation; Knowledge of pharmacological and medical terminology

4. Comprehensive knowledge of drug development and commercialization processes, and related business implications

百时美施贵宝是一家以“研发并提供创新药物，帮助患者战胜严重疾病”为使命的全球性生物制药公司。

2019年11月20日，百时美施贵宝成功完成了对新基的收购，将双方在领先的科学、创新的药物和优秀的人才等方面的优势合二为一，打造全球领先的生物制药企业。公司在肿瘤、血液、免疫和心血管疾病等领域处于世界前列，并具有丰富的，且具有行业前景的产品管线。

如今，中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一。我们致力于满足中国未被满足的迫切的重大疾病需求，引领行业发展，开展多元合作，以帮助中国患者战胜严重疾病。