长沙招聘

Accountabilities
- SOPs:
· Ensures local processes and procedures are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations.
- Compliance:
· Ensures a local tracking system is in place, to ensure timely submissions of adverse events to Abbott Global Pharmacovigilance (GPV), and of ICSRs and Periodic Reports to the Regulatory Authority.
· Reports monthly compliance metrics to GPV within the required timelines.
· Maintains awareness of local PV legislation.
· Ensures GPV is promptly notified of any changes to relevant Local Legislation.
· Co-ordinates Affiliate review and submission of periodic safety reports.
· Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies.
· Ensures any changes to Affiliate safety personnel are communicated to the Regulatory Authority (if required by national legislation), GPV and the EU QPPV (if applicable) in a timely fashion.
- Adverse event processing:
· Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events from spontaneous and solicited sources and SAEs from clinical studies (where applicable), including pregnancy, overdose, misuse, abuse, medication errors or product quality complaint reports (in association with QA).
· Ensures local language medical or scientific literature, not included in GPV global literature review, are reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV.
- Product complaints:
· Ensures product complaints are reviewed for adverse events, and forwards any AEs identified to GPV.
· Completes reconciliation between QA and PV at the Affiliate, ensuring that all ICSRs have been identified.
- Safety Data Exchange (SDE) Agreements:
- Ensures content of local agreements is in line with Abbott standards
- Maintains compliance with local agreements, including reconciliation between partner companies
· Ensure the content of local SDE agreements conforms to Abbott standards and local requirements.
· Submits all local SDEAs to QSCTO, GPV for approval prior to finalization.
· Ensures a local tracking system is in place, to monitor compliance to local safety data exchange agreement timeframes.
- Training:
· Maintains a version-controlled training matrix for local PV personnel.
· Ensures training of affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis, and that appropriate training records are maintained.
· Ensures that any training of partner company staff is completed according to local contract requirements, and appropriately documented.
- Audits and Inspections:
· Acts as the key Affiliate contact for both internal audits and Regulatory Authority inspections.
· Ensures that any Regulatory Authority communications are forwarded to the required GPV personnel and that any corrective actions are completed according to schedule.
- Risk management (RM):
· Is a member of the Affiliate Risk Management Team.
- Safety Monitoring:
· Monitors the risk/benefit profile of local products and communicates changes or concerns to Global Pharmacovigilance (GPV) and the Qualified Person Responsible for Pharmacovigilance (QPPV) (if applicable) for evaluation.
- After Hours Availability:
· Ensures that an after hours process is in place and tested (e.g., to respond to Regulatory Authority questions and for emergency un-blinding of treatment codes for Abbott sponsored studies).
· Maintains up- to-date information on local Regulatory Authority out of hours contacts.
- Response to medical inquiry timely


Knowledge, Skills & Experience
- Bachelor degree or above;
- Medical, pharmacy or life-sciences degree (or equivalent);
- Previous experience of working within the pharmaceutical industry and, in particular, pharmacovigilance is preferred, but not mandatory;
- Fluent English in reading, writing and oral communication.

服务于全球医疗保健需求
我们是一家全球性的多元化医疗保健公司，致力于探索维持健康的新药品、新技术和新方法。我们的产品跨越整个医疗护理领域，从营养品和诊断产品到医疗器械和医药治疗方案。我们全线产品系列贯穿各个年龄段，满足从婴幼儿到老年人的重要健康需求。
公司在全球范围内拥有销售、制造、研发以及分销等网点，我们时刻为客户和患者着想，因此我们会随时出现在他们最需要的地方。我们的全球影响力和客户服务能力获得了广泛认可。

科学传递关爱
在我们120多年的发展历程中，雅培人一直为着一个永恒的目标而不懈地努力：推动医疗科学进步，帮助人们更健康地生活。这也是我们公司优良传统的一部分并且将继续推动我们不断向前。今天，雅培全球70,000名雅培员工共同激情投入"科学传递关爱"的行动。
这是雅培的承诺，我们相信生命拥有无限潜能，我们愿意为这份崇高的事业贡献力量。

良好的工作环境
在雅培，我们提供优良的工作环境，并被公认为优秀雇主，对此我们倍感自豪。我们以承诺提供优越的工作场所而获得了众多本地，全国及国际性的荣誉。雅培员工知道他们所得到的都是最好的—从获奖医疗保健福利到各种便利和福利服务及长期退休福利。

致力于全球领先的健康事业
我们把对生活的改善延伸到人道主义事业。作为一个生产创新型医疗保健产品的领导者，雅培认为这是我们特殊和使命来帮助人们—无论他们处于贫穷或是灾难。我们都将坚定不移地通过创新和多项社会活动来完成这项职责。

雅培成熟药品部
雅培成熟药品部（EPD）目前在中国有1200名左右员工, 拥有消化及肝病，妇科及神经科，心血管及泌尿科，疫苗产品领域的13个产品。我们诚邀充满激情，实干的精英加入我们的团队。

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https://www.abbottcareers.com/

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