梧州招聘

Job Description
The Medical Safety Physician for China serves as medical safety support at CPO China for cross-functional safety activities including DS&E, Medical Affairs, DRA, Marketing, Legal, and Communication on drugs and marketing brands in China. The Medical Safety Physician for China also ensures a bridge of communication with global program/brand team (GPT/GBT), global DS&E team including the Therapeutic Area Safety Leader (TASL), Brand Safety Leader (BSL) and Pharmacovigilance Leader (PVL) in charge of specific drugs/brands. The Medical Safety Physician for China is responsible for the communication with the Chinese Health Authorities (SFDA) on drug safety related aspects including response to SFDA queries. "
1. Develops and maintains internal collaborations including with Global (Global DS&E, and GPT/GBT) and within the CPO (CPO DS&E, Medical Affairs, DRA, Marketing, Legal, and Communication) for drugs/brands safety related activities in China.
2. Reviews safety data from various local sources, in collaboration with the product specific Global PVL/BSL is responsible for medical assessment of individual local drug/brand safety cases and ensures the collection of full follow-up information for those cases.
3. Provides in consultation with the Global Safety Brand team support to Medical Affairs for the safety issue management and over-all coordination with the local drug/brand Committee. Provides as required expert medical safety input to the Local Franchise in regard with the strategy of local programs.
4. Contributes to the development and maintenance of key internal Novartis local safety documents based on information from all relevant line functions, post marketing data, and other sources (incl. line listings of single cases).
5. Responsible for updates of safety information in local project/product labeling claims related to specific drug/brand.
6. Provides expert medical/scientific input into key safety deliverables related to drugs/brands including internal local deliverables (e.g., regular safety profile summary), internal global de-liverables (e.g., Periodic Safety Update Reports - PSURs, or RMP) and external deliverables (e.g., investigational reports on death cases, product safety summary for licensing renewal).
7. Provides support to local Legal department and Medical Affairs in case of claim from patients in China involving a Novartis drug.
8. Leads the external communication on safety topics related to a Novartis drug including with the local Health Authorities (SFDA) and the local Key Opinion Leaders (KOL).
9. Responsible for responses to inquiries from regulatory Health Authorities or health care pro-fessionals on safety issues related to a Novartis drug. Prepares safety data for Health Authori-ties review boards.
10. Ensure safety information is communicated to Global DS&E (TASL and QPPV Office) in a timely manner.
11. Facilitates involvement of external experts (e.g. members of trial/program specific data safety monitoring boards, ad-hoc support for Health Authority meetings, etc.).
12. Provides support as needed for licensing activities, regulatory Authorities inspections and for local project/product recall activities. "
Minimum requirements
Medical Degree required. Useful additional degrees: postgraduate degree in Pharmaceutical Medicine. Experience in in-fectious diseases/hepatitis. " "? Fluent in Chinese ? Fluent in spoken and written English" "? 3 years clinical experience postdoctoral and/or at least 3 years progressive experience in drug development in a major pharmaceutical company ? Expertise and demonstrated leadership in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety in-formation ? Strong experience with (safety or others) issue manage-ment ? Excellent written and verbal communication skills ? Experience with managing large and complex documents, with demonstrable customer focus and quality.

北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药，涵盖的疾病领域包括：心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。

“诺华”中文取意“承诺中华”，即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年，总部设在北京，隶属于瑞士诺华公司。

诺华公司致力于为患者及社会提供创新医药保健解决方案，以满足其日益变化的健康需求。2011年，集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元（去除减值及摊销后为92亿美元）。诺华集团总部位于瑞士巴塞尔，业务遍及全球140多个国家和地区，拥有124,000位全职员工。诺华集团立足在中国的长期发展，重要战略投资包括位于上海的综合性生物医学研发中心，以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息，敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。