长沙招聘

Job Purpose

To support management of DS&E operational processes at Country Pharma Organization (CPO) in ensuring compliance with Novartis global/local procedures, Chinese and international regulations/ standards/guidelines for pharmacovigilance of Novartis marketed and investigational products.

Major Responsibilities

1. Manage collection, processing, documentation, reporting and follow-up of all adverse events
(AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, commercial programs, etc.
2. Ensure accurate and consistent transcription, translations and data entry of all Serious
Adverse Events (SAE) from source documents onto safety systems (e.g. SINA, ARGUS, etc)
with emphasis on timeliness and quality.
3. Ensure recording and tracking of receipts, submissions and distributions of SAEs, SRs, Investigator Notifications (IN), Periodic Safety Report Updates (PSUR).
4. Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE,
SR, IN, PSUR, ASR) to Local Health Authority (LHA) and/or clinical operations.
5. Work with other local/global DS&E associates to ensure accurate evaluation of safety data.
6. Interact and exchange relevant safety information with Local Health Authority, other functional groups and third party contractor, if applicable.
7. Survey and monitor Chinese pharmacovigilance regulations and provide update to global
DS&E organization.
8. Set up, update and implement local procedures to ensure compliance with DS&E global procedures and Chinese requirements.
9. Input, review and approval of program proposals for language, content and establishment of
necessary controls on collection and reporting of adverse event information.
10. Assure reconciliation is performed with other departments (e.g. Medical Information, Quality Assurance, Customer Service Centre and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.
11. Management and maintenance all relevant DS&E databases.
12. Ensure timely preparation and submission of KPI reports on AE reporting including
identification of root cause(s) for late reporting to Local Health Authority, development and implementation of corrective action(s) as needed.
13. Develop and update training materials for pharmacovigilance and ensure training of CPO associates on relevant DS&E procedures for AE reporting, including field force and third party
contractor, if applicable.
14. Ensure support for and close-out of audits, corrective action plan, investigation and Health
Authority inspections.
15. Ensure training and oversight of staff, as applicable.
16. Manage and maintain efficient DS&E filing and archive system.
17. Ensure RMP implementation in PVO and coordination of RMP activities in CPO.

Ideal Background

Education:A degree in medicine, pharmacy, health discipline or life sciences

Languages:

- Fluent in both written and spoken English

- Good working knowledge of Chinese

Experience/Professional

- 1-3 years pharmaceutical or clinical research experience, pharmacovigilance experience preferred
- Knowledge of Chinese regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology.
- Excellent communications, interpersonal and negotiation skills.
- Computer knowledge

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。