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周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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无工作经验 -
招1人 -
11-09 发布
职位描述
职位描述： Overall goals of the position:The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and product life cycle safety management. The Medical safety scientist has additional responsibility to those in that the incumbent is expected to play a greater role as a senior technical leader and participate more fully in matrix management activities including preparation or participation in evaluating safety issues, label, clinical study sectors and review the data generated from aggregate reports and PSUR in collaboration with pertinent GMS channels. This will be demonstrated by preparing sections of aggregate safety reports and annual safety summary, ad-hoc regulatory reports, required Risk Management Plans etc, interpretation of safety surveillance and product quality data. In addition, the Medical Safety Scientist will work in conjunction with China Safety Operational team and GMS and be responsible for safety surveillance activities and risk communication for selected and/or targeted products. This medical safety expertise will be reflected in activities such as managing product therapeutic area or project team, participating in cross-functional projects such as labelling review committee, taskforces, work streams etc and representing Janssen China safety positions, processes and guidance to external business partners.PRINCIPAL RESPONSIBILITIES:? Medical evaluation of individual adverse event case safety reports,including but not limited to all serious and expedited reports in clinical study or marketed environment; S/he should have ability to learn from GMS initially to make individual case assessment and evaluation in China R&D clinical project or ad hoc project;? Accountable for clinical safety review, recommendation and interpretation, analysis and summarization of aggregate safety data and periodical data from all sources including spontaneous, clinical, postmarketing and observational studies, literature review and product quality (e.g. safety summary and regulatory inquiry etc) per regulations and the requirements;? Provide therapeutic area/pharmacovigilance issue and guidance in single case assessment and ensure proper communication with project team;? Participate local labelling review activities and meetings for execution of pharmacovigilance components of Risk Management Programs and related activities including assessment of potential signals;? Participate as core members of crisis management responsible for pharmacovigilance activities focused on individual products and pertinent therapeutic areas; Responsibilities include training activities, contributing to the development and implementation of risk minimization action plansetc;? Assist/present in the preparation and review of ad hoc reports pertaining to safety-related matters;? Assist in the review of literature publications following established procedures for safety reporting purposes;? Ad hoc to ensure due diligence in supporting decision making and characterizing adverse events.EDUCATION & EXPERIENCE REQUIREMENTS:1. Degree/Advanced degree in clinical medicine or pharmacy, appropriate post-medical degree / specialtyaccreditation strongly preferred;2. Drug safety experiences in PV or clinical research or drug development in international pharmaceuticalcompanies at least 4-6 years;3. Good problem solving and decision making skill;4. Strong interpersonal skills, with a demonstrated ability to foster team work;5. Ability to manage discussions and decision making;6. Excellent communication, conflict management and negotiation skills;7. Good English/Chinese communication skill (written and verbal);8. Opening, optimistic and easy going personality;9. Good computer application skills. 职能类别： 药品生产/质量管理
联系方式
北京市朝阳区建国路77号华贸中心写字楼
公司信息
公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国最大的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。 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。
