EG-Sr. Drug Safety Specialist(J24103)社

面议

市辖区本科及以上4年及以上

发布时间：2023-09-06

职位描述

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 Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.
How You Will Achieve ItContribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Provide oversight, team mentoring on case handling aspects, data extraction and analyses and conduct follow-up activities.
Act as subject matter expert and liaise with key partners regarding safety data collection and data reconciliation.
Review, analyze, prepare, and complete safety-related reports within scope to determine the safety profile of Pfizer
s products and to meet regulatory requirements.
Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
Manage, where applicable, safety resources in the local team.
Provide specific pharmacovigilance or product knowledge and experience, as required by the business, and mentor colleagues accordingly.
Develop and maintain advanced knowledge of all products within the Pfizer portfolio.
Develop and maintain expertise of all assigned products, of applicable corporate policies.
Design and oversee the tracking of applicable safety metrics.
Manage project and process management meeting established deadlines.
And search functions in the safety database and data mart.
任职资格:
QualificationsMust-HaveBachelor
s Degree
3+ years
experience
Demonstrated organizational/project management skills
Solid knowledge of global regulations and guidelines for drug development
Demonstrated analytical and statistical skill.
Ability to make decisions independently and resolve issues appropriately
Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
Fluent in spoken and written English
Nice-to-HaveMaster
s degree
Relevant pharmaceutical industry experience
Familiarity with management of performance metrics
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

其他要求

招聘人数：1人
职能类别：药物安全/药物警戒PV

公司介绍

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。