长沙招聘

工作职责:

Why Patients Need YouPfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will AchieveYou will be relied on by the company to monitor its drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post marketing activities.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve ItOrganize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity

Carry out all case management activities as appropriate

Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested

Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

Ensure complete and timely forwarding of ICSR to Core

Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed

Consistently apply regulatory requirements and Pfizer policies

Analyze and monitor activities, define and implement corrective actions, where applicable

Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database

Provide oversight and team mentoring on case handling aspects, data extraction and analyses

Manage, where applicable, safety resources in the local team

Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the GPO DSU organization

Act as subject matter expert for the DSU within WWS

Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners (e.g., BUs, License Partners) regarding safety data collection and handling

Promote/participate, as appropriate, in local, internal and external safety activities

Technical Skill RequirementsUnderstanding and ability to use computer technology, management of relational database systems, including extraction of data

Solid working knowledge of pharmacovigilance concepts

Solid knowledge of national and international regulations

Solid understanding of medical terminology

Solid knowledge of global regulations and guidelines for drug development

任职资格:

Qualifications (i.e., preferred education, experience, attributes)Health Care Professional or equivalent experience preferred

Minimum 4 years’ experience in pharmacovigilance and/or data management, clinical care or clinical or scientific research required

Experience and skill with medical writing an advantage

Ability to independently solve routine problems related to case processing and surface issues constructively

Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact

Ability to discern when additional input is required to effectively address unique and/or complex situations

Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals

Ability to work independently to accomplish team goals with minimal supervision

Demonstrated ability to foster teamwork

Fluency in spoken and written English

 

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。