Specialist, Chinese Case Management,PV
西安杨森制药有限公司
- 公司规模:1000-5000人
- 公司性质:合资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-11-09
- 工作地点:北京-朝阳区
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:本科
- 职位月薪:0.8-1万/月
- 职位类别:药品生产/质量管理
职位描述
Job Responsibilities:
- Work closely with local medical safety and regional IPV affairs team to meet company business and compliance needs;
- Management and oversight of case management work of China team; ensure company product safety information timely reporting to health authorities, Johnson & Johnson GMS and contractual partners in compliance with China regulations, J&J policies and pharmacovigilance agreements;
- Support global implementation projects for new Procedures and Systems for IPV and coordinate IPV impact assessments to meet global standards and local applicable laws and needs;
- Support IPV in building and maintaining inspection readiness for all IPV related activities;
- Support global IPV processes in cooperation with relevant SMEs and stakeholders;
- Support a globally consistent approach for assessing, recording and reporting of countries compliance status in close cooperation with CSA international. Escalate alert signals of non-compliance. Focus on risk identification and support mitigation as needed;
- Support continuous improvement initiatives based on quality and compliance Key Performance Indicators;
- Contributing to the development of an standardized and integrated IPV quality system;
- Closely collaborate with CSA international to develop a Corrective and Preventive Action (CAPA) monitoring system and monitoring and follow-up on CAPAs, escalating non-adherence;
- Support targeted IPV projects based on prioritization by the IPVLT to measurably improve global, regional and Local Operating Company PV compliance and efficiencies in operations;
- Coordinate and own country/ regional CAPAs as applicable;
- Ensure oversight and coordinate LSO assignments to regional and global projects (SMEs);
- Implement strategy for composition and maintenance of IPV Curricula in close cooperation with CSA International;
- Support roll-out of new/revised role profiles and competency model;
- Support country/APAC region to develop strategy for LSO onboarding programs.
Qualifications:
- Medical, pharmacy or life-sciences degree (or equivalent);
- Experience working in the pharmaceutical industry is strongly preferred;
- Extensive experience in conducting training;
- Knowledge of PV regulations;
- Experience using global safety database desirable;
- Demonstrated attention to detail;
- Excellent written and spoken communication and presentation skills;
- Effective decision maker with the ability to assess impact of actions taken locally on the global PV system;
- Fluency in written and oral English in order to facilitate communications with GMO, regional Medical, other global functions, and Health Authority;
- High customer orientation;
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity;
- Sound judgment, strong planning and organizational skills, and the ability to get things done;
- Demonstrated strong sense of urgency;
- Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety;
- Project Management experience including stakeholder management and change management experience is preferred.
职能类别:药品生产/质量管理
公司介绍
本着公司信条和关爱精神,西安杨森一直是活跃的企业公民,在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如,西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”,旨在鼓励医药学领域的工作者不断创新。在过去的17年中,共计305名杰出医药学工作者在45个专业领域获得了该奖项,他们在科研领域做出了大量有价值的创新。 此外,西安杨森也被誉为培养制药行业人才的摇篮。1999年,西安杨森被财富杂志(中文版)评选为“中国最受敬仰的十大外资企业之一”。2005年,西安杨森被中国中央电视台评选为“***雇主”,并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。
目前西安杨森所有的招聘信息仅通过前程无忧,智联招聘和猎聘网进行发布,任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害,请务必通过正规渠道投递简历。
2013年,强生在西安高新区投资兴建强生全球供应链先进的生产基地,该项目建设目前已正式启动。新生产基地占地267,000平方米,将取代西安杨森在西安新城区现有的生产基地,成为强生供应链在亚洲的创新枢纽,从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系,并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。
联系方式
- Email:tmao3@its.jnj.com
- 公司地址:北京市朝阳区建国路77号华贸写字楼3座 (邮编:100025)