PVO Associate/Assistant(Contractor)
北京诺华制药有限公司
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2014-05-06
- 工作地点：北京
- 招聘人数：1
- 工作经验：一年以上
- 学历要求：本科
- 职位类别：药品生产/质量管理 临床数据分析员
职位描述
该职位与FESCO签订劳动合同，享受国家规定社会保险，补充医疗保险商业保险等。
Job Purpose (Briefly state in one sentence the overall objective of the role)
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 (Describe main activities)
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.
Key Performance Indicator (Indicate how performance for this role will be measured)
1. Organization and management of DS&E operations
2. CPO Accreditation on AE reporting compliance
3. Quality and timely reporting of KPI and safety reports/updates
4. Results of audits/inspections
5. Customer feedback
Job Dimensions (Indicate key facts and figures)
Number of associates: None
Financial responsibility: Nil
(Budget, Cost, sales, etc.)
Impact on the organization: Critical, a significant compliance failure could result in an enforced cessation of business.
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
Job Purpose (Briefly state in one sentence the overall objective of the role)
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 (Describe main activities)
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.
Key Performance Indicator (Indicate how performance for this role will be measured)
1. Organization and management of DS&E operations
2. CPO Accreditation on AE reporting compliance
3. Quality and timely reporting of KPI and safety reports/updates
4. Results of audits/inspections
5. Customer feedback
Job Dimensions (Indicate key facts and figures)
Number of associates: None
Financial responsibility: Nil
(Budget, Cost, sales, etc.)
Impact on the organization: Critical, a significant compliance failure could result in an enforced cessation of business.
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
公司介绍
诺华正在通过创想医药未来，改善人们的生活质量、延长人类的寿命。作为全球知名的医药健康企业，我们运用创新科学和数字化技术，在医药健康需求增长的领域创造变革性的治疗方法。在探索新药物的过程中，我们不懈创新，对研发的投资一直处于行业全球先列。在全球，近8亿患者受益于诺华产品，同时，我们持续探索更多创新方式使我们的创新疗法造福更多患者。诺华在全球拥有来自超过140个国家的约11万名员工。
诺华在中国的经营活动可追溯到200多年前。早在1886年，嘉基公司就开始在中国推广染料，此后汽巴公司与山德士公司也先后进入中国市场。1970年，嘉基公司和汽巴公司合并；并于1987 年在华成立北京汽巴-嘉基制药有限公司，这就是北京诺华制药有限公司的前身。1996年，汽巴-嘉基和山德士合并成为诺华公司诺华在中国的业务包括诺华肿瘤、诺华制药和山德士，全国建有两大生产基地，并在北京、上海和江苏设立了研发机构。从研发到生产销售，诺华以多元化的业务组合，全面服务中国老百姓的健康。目前，诺华在中国拥有8000多名员工。
关注诺华招聘公众号，创想职业精彩未来！
诺华在中国的经营活动可追溯到200多年前。早在1886年，嘉基公司就开始在中国推广染料，此后汽巴公司与山德士公司也先后进入中国市场。1970年，嘉基公司和汽巴公司合并；并于1987 年在华成立北京汽巴-嘉基制药有限公司，这就是北京诺华制药有限公司的前身。1996年，汽巴-嘉基和山德士合并成为诺华公司诺华在中国的业务包括诺华肿瘤、诺华制药和山德士，全国建有两大生产基地，并在北京、上海和江苏设立了研发机构。从研发到生产销售，诺华以多元化的业务组合，全面服务中国老百姓的健康。目前，诺华在中国拥有8000多名员工。
关注诺华招聘公众号，创想职业精彩未来！