Sr. PV Operation Manager, China
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
主要工作职能Primary Job Function:
作为个人贡献者负责协助管理与雅培营养品相关的安全信息的收集处理和维护工作确保这一过程符合适用的法规要求和指导原则同时协助确保为已注册为药品的雅培营养品建立的药物警戒体系到位并符合公司及监管标准
As an individual contributor assists in managing the receipt processing and maintenance of safety related information as it relates to Abbott Nutrition products in compliance with applicable regulatory requirements and guidelines. Assists in ensuring that the pharmacovigilance system in place for Abbott Nutrition products registered as drugs is in place and is in compliance with corporate and regulatory standards.
核心工作职责Core Job Responsibilities:
- 不良事件管理负责及时且合规地接收处理交流和提交雅培营养品在临床试验和上市后的个例安全报告ICSRs以满足适用的监管要求和全球要求
- 供应商管理管理与供应商的沟通与合作确保他们遵守相应的药物警戒协议/标准操作规程SOPs/工作指示WIs/法规
- 安全培训协助确保所有附属公司的员工和承包商都了解他们完成年度不良事件识别和报告培训的责任确保附属公司人员每年至少接受一次关于相关药物警戒职责的培训并保持和维护适当的培训记录及文档
- 汇总安全报告支持支持协调定期安全性更新报告PSURs/周期性效益风险评估报告PBRERs药物警戒年度报告药物年度报告临床试验安全报告以及其他当地要求的汇总安全报告的审查和提交
- 审计与检查支持内部药物警戒审计和监管机构的药物警戒检查
- 药物警戒体系维护维护和监督在中国注册为药品的雅培营养品产品的药物警戒体系协助QPPV确保当地流程和程序到位并符合全球SOP和当地法规
- 支持亚太地区其他国家的药物警戒活动为亚太地区其他国家的药物警戒活动提供支持
- Adverse Event Management: receipting processing exchanging and submission of Individual case safety reports (ICSRs) in clinical trail and post-marketing for Abbott Nutrition products in a compliant and timely manner to meet applicable regulatory requirementsand global requirement.
- Vendor managment: Manage/commuinicate with vendors to make sure they are compliant with the corresponding PV agreements/SOPs/WIs/regulations.
- Safety Training: Assists in ensuring all Affiliate employees and contractors in Affiliate are aware of their responsibility to complete annual adverse event identification and reporting training. Ensures training of Affiliate personnel on relevant pharmacovigilance responsibilities is undertaken at least annually and that appropriate training records are maintained and appropriately documented.
- Aggregate Safety Report support: Support to coordinate review and submission of PSURs/PBRERs PV Annual Reports Drug Annual reports clnical trail safet reports and other locally required Aggregate Safety Reports.
- Audits and Inspections: Support both internal pharmacovigilance audits and Regulatory Authority pharmacovigilance inspections.
- Pharmacovigilance system maintanence: Maintances and oversights the pharmacovigilance system for Abbott Nutrition products registered as drugs in China. Works with QPPV to ensure local processes and procedures are in place that are aligned with global SOPs and local pharmacovigilance activities in other countries in the Pacific Asia region.
职位/责任范围Position Accountability/Scope:
财务影响体现在部门层面并直接源于违规或响应时间延迟能够独立安排工作优先级不参与制定战略决策但负责支持部门事业部和公司的战略方向工作职责与任务相关包括更高层次的工作职能例如安排工作优先级进行培训独立汇编报告数据确保合规可能会因参与特定项目或承担培训职责而增加跨部门接触的机会工作对组织的合规性有重大影响
Financial impact is at the department level and directly results from either non-compliance with regulations or delayed response time. Able to prioritize workload independently. Does not initiate strategic decisions but is responsible for supporting the department division and companys strategic direction. Workload responsibilities are task-related and include higher level functioning (ex: prioritizing workload training independently compiling data for reports ensuring compliance with regulations). May have additional interdepartmental exposure based on specific project involvement or training responsibilities. Work has a major impact on the organizations regulatory compliance.
最低教育要求Minimum Education:
拥有生命科学医学药学等相关领域的学士学位或者具备同等的教育背景和工作经验组合以使个人具备执行该职位所必需的知识技能和能力
Bachelors degree in related life sciences medical pharmacy or an equivalent combination of education and experience that gives the individual the necessary knowledge skills and abilities to perform the job.
最低经验/培训要求Minimum Experience/Training Required:
最好具备与制药行业合作的经验拥有8-10年的药物警戒相关工作经验
了解国内区域及全球与营养品和药品相关的法规
熟悉部门标准操作规程SOPs并具备将临床知识应用于不良事件数据收集和处理的能力
英语书面表达流利能够准确翻译和呈现安全概况/数据
熟练掌握计算机操作WindowsWordExcel并能熟练使用不良事件数据库
具备良好的书面和口头表达能力以及沟通协调能力
组织能力强能够证明自己有优先排序和同时处理多项任务和项目的能力
严格遵守相关规则和程序对科学质量和诚信有着强烈的承诺
- Better to have Previous experience working with pharmaceutical industry 8-10 year pharmacovigilance relevant experience.
- understanding of domestic reginal and global regulations related to nutritional products and drugs.
- Understanding of department SOPs and clinical knowledge to apply to adverse event data collection and processing.
- Fluency in written English is essential in order to accurate translation and presentation of safety profile/data.
- Computer proficient (Windows Word Excel) and proficient in working in adverse event databases.
- Good communication and interpersonal skills both written and spoken.
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
- Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Product Development
DIVISION:
ANRD Nutrition Research & Development
LOCATION:
China > Shanghai : 1036 Tianlin Road Caohejing Business Park SBP Phase III
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Key Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
