天津招聘

职位描述：
岗位职责:

PHARMACOVIGILANCE MANAGER - CHINA
Description
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

We have a new and exciting opportunity to hire a Pharmacovigilance Manager, for our Pharmacovigilance here at China’s office.

Job Purpose and Scope:
The primary objective of this position is the organization, collection, and submission of safety information for Baxter Healthcare products (primarily adverse events and adverse reactions) to Baxter Global Pharmacovigilance and to the regulatory authorities in compliance with Baxter’s policy and local regulatory requirements. Represent as China Pharmacovigilance to internal and external stakeholders.

Core Job Responsibilities:
? Prepare reports for spontaneous adverse events of marketed products and clinical serious adverse events.
? Review all adverse events collected and forward adverse events that meet reporting criteria to Baxter Product Safety areas and local regulatory agencies according to local and global SOPs.
? Ensure appropriate follow-up of all spontaneous reports of adverse events to marketed products and serious adverse events for clinical trials.
? Track compliance for adverse event reporting timeframe. Assist management with identifying any trends and issues arising from reports from the local safety database and from periodic safety reviews. Alert the management to any issues.
? Liaise with local affiliate departments to ensure compliance with Pharmacovigilance SOPs.
? Maintain up to date knowledge of pharmacovigilance requirements.
? Review local and global SOPs and pharmacovigilance guidelines. Communicate to management any important changes.
? Review and implement affiliate pharmacovigilance staff training matrix. Ensure that all aspects of Pharmacovigilance training meet local and global requirements.
? Conduct Drug Safety Training for affiliate personnel.
? Reviews related Safety Reports for changes in risk/benefit profile and communicate information to management.
? Assist in review/writing of local SOPs.
? Assist with internal audit of quality complaints and product safety information queries for issues/trends.

任职资格:

Qualifications
Experience, Skills and Knowledge:
? Experience with either pharmacovigilance or knowledge of adverse event reporting in post-marketed products and clinical trials or knowledge Malaysian regulatory authority regulations
? Medical, pharmacy or life-sciences master degree (or above), Previous experience of working within the pharmaceutical industry on pharmacovigilance is preferred, or has extensive experience(> 3 years) on clinical research may be an alternative
? Proactive
? Excellent communication skills
? Excellent organisational skills
? Excellent team working skills
? Project management skills
? Time management skills
? excellent command of written and spoken English

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百特国际有限公司提供肾科与医院关键产品的广泛组合，包括居家透析、急重症透析和中心透析产品；无菌静脉输液；输注系统与设备；肠外营养；生物外科产品与麻醉；以及药房自动化、软件和服务。公司凭借全球布局，以及其产品与服务的必需性，在提升新兴与发达国家市场医疗可及性方面发挥至关重要的作用。百特在全球的五万名员工，秉承公司在医疗创新领域的深厚积淀，持续推动未来的医疗创新，更好地满足患者的医疗需求。

Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.