[回复本文][原帖] 发信人: Nicolelike(维尼), 信区: JobInfo
题: 【全职】辉瑞中国研发招聘通知(PSSR Aggregate
发信站: 饮水思源 (日09:42:25 星期三)
感兴趣的同学可以在截止日期之前将中英文简历发送至NicoleKe.，请勿投
条，谢谢！
Position Title/职位名称 PSSR Aggregate Report Analyst (Manager/Sr. Manager lev
el)（3 vacancies）
Department/部门 Worldwide Safety & Regulatory Operations (WSRO)
Working Location/城市 Shanghai
Deadline/截止日期 August 31,2012
Role Description
Position Title: Product Safety Surveillance & Reporting Aggregate Report Anal
Duration of Assignment: Permanent
Division/Organization: Pfizer Medical/WSRO
Line: Safety Evaluation and Reporting (SER)
Department: Product Safety Surveillance & Reporting (PSSR)
Location(s):
Organizational Relationship(s) including to whom the position reports (title):
 Reports to Therapeutic Area Team Lead Aggregate Reports
Position Purpose
The PSSR Analyst role provides documents clearly summarizing a drug’s risks a
nd benefits.
In conjunction with the project team and with colleagues in Worl
dwide Safety Strategy (WSS) and Worldwide Safety & Regulatory Operations (WRSO
), he or she will contribute to understanding and communicating risk and risk/
benefit, through essential written deliverables. These include but are not lim
ited to integrated analyses of safety data in support of aggregate reports (e.
g., Periodic Safety Update Reports, NDA Periodic Adverse Drug Experience Repor
ts, etc.), responses to regulatory questions, post-marketing safety assessment
for potential changes to labeling documents.
Specific tasks are assigned ac
cording to the incumbent’s expertise, training and capacity.
In producing th
ese, the analyst applies expert knowledge, analytical skills, knowledge of cli
nical and regulatory guidance and scientific and medical literacy.
These deli
verables will enable Pfizer product teams to optimize the chance of license ap
proval with a commercialisable label and appropriate maintenance of post marke
ted products.
Delivery of some of these documents may be by matrix management
of, or collaboration with, other analysts, epidemiologists and authors in WSR
O, WSS, or Worldwide Development.
Primary Responsibilities
 Consult with the project or product teams to determine the key messag
es for documents with consideration of proposed labeling statements.
 Partner with project or product team members in preparing commissione
d deliverables.
 Establish and chair document working groups comprised of authors and
subject matter experts (SMEs) from the project or product teams, as necessary.
 Ensure high quality written presentations of integrated clinical data
compliant with regulations, ICH guidelines, and corporate SOPs for review and
assessment, implement systems and processes to achieve this and suggest proce
ss improvements.
 Communicate resource, timeline and emerging data interpretation issue
s that have regulatory impact, to the project team and line management.
 Develop and sustain constructive relationships within WSS, WSRO and w
ith Worldwide Regulatory Strategy, Development Operations, Clinical Sciences,
Pfizer Country Offices medical departments, Marketing and other stakeholders.
Technical Skill Requirements
 Knowledge of case processing and aggregate reporting requirements.
 Demonstrated proficiency with computer applications and understanding
of safety data.
 Knowledge of global safety database.
 Knowledge of pharmaceutical business, including drug development and
regulatory aspects.
Qualifications (i.e., preferred education, experience, attributes)
 Scientific/medical academic background (MSc/BSc with clinical trainin
g/experience), or equivalent, ideally with experience in drug development, cli
nical pharmacology, and/or pharmacoepidemiology within the pharmaceutical indu
stry, regulatory agencies or academia.
 Knowledge of US and international regulatory/safety regulations and g
 Experience working with the safety databases
 Strong organizational skills and ability to prioritize multiple proje
cts and meet deadlines
 Extensive experience in Safety, Regulatory or Clinical Development an
d business experience
 Effective influencing and negotiating skills
 Fluency in oral and written E knowledge of additional language
(s) an advantage
 Excellent presentation skills
 Strong risk management expertise, ability to demonstrate strategic th
inking and solid analytical skills
我想就这样牵着你的手不放开
!yieshen.m!:·饮水思源 bbs.·[FROM: 204.114.176.11]
Pursue your object, be it what it will, steadily and indefatigably.
　wwngjieseng.om@　
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名企校园招聘符合“Pssr”的前 4 位会员 - Wuhan
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真人分享（辉瑞制药）
辉瑞制药 - PSSR工资详情(武汉，2014年)
此信息由圈友于2014年10月分享，其分享的是2014年的经验及资料
工资待遇（PSSR） 基本工资：
津贴补助：
绩效工资： 年终奖：
辉瑞制药 - PSSR工资待遇(武汉，2014年)
上班时间（PSSR） 能否准时下班： 周六周日是否加班： 每年带薪年假： 每周工作天数：
保险及福利（PSSR） 社会保险（5险）： 是否有公积金：
工作满意度（PSSR） 工作环境/氛围好吗？： 工作压力大吗？： 公司管理怎么样？： 在公司能否学到东西？： 是否后悔进入这家公司？：
分享时间：2014年10月
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