北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医药技术研发管理人员招聘

Senior Manager, PSSR Team Lead

辉瑞(中国)研究开发有限公司

  • 公司规模:10000人以上
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2014-04-21
  • 工作地点:武汉
  • 招聘人数:1
  • 职位类别:医药技术研发管理人员  

职位描述

Organizational Marketing Statement

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description

Develop and maintain knowledge of applicable SOPs, Safety Job Aids and the Argus User Reference Guide.
Develop and maintain current knowledge of assigned products within a therapeutic area.
Maintain working knowledge of applicable corporate and global regulations/guidelines.
Develop an understanding of the importance of ICSR processing to aggregate report quality and timeliness.
Contribute to ‘Right First Time’ initiatives.

Responsibilities

Manage the case-flow process across a multi-functional therapeutic team to ensure timely and accurate processing of adverse event cases to meet corporate and regulatory reporting requirements.
Provide oversight and guidance to Safety Assessment Associates on review and processing of adverse event reports.
Manage the team’s case processing to ensure complete and timely submission to the PSSR aggregate reports group.
In cooperation with the Therapeutic Area Head and Business Planning Leads, manage available resources to ensure effective processing of PSSR caseload, processing cases when necessary.
Take responsibility for implementing the corrective actions resulting from timeliness or quality issues associated with case processing.
In the absence of the Therapeutic Area Head, act as point of contact for the therapeutic area team.

Technical Skill

Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork.
Demonstrable understanding of safety report processing and assessment of safety at the Technical Supervisor level; ability to process cases an advantage.
Demonstrable skills in project, time and change management, organizational and facilitation skills.
Good understanding of medical terminology and familiarity with principles of clinical assessment of safety reports in the context of an international pharmaceutical industry.
Knowledge of global regulations governing safety reporting.
Demonstrable organizational and time management skills, in order to meet strict regulatory compliance goals.

Qualifications

Minimum of three years research, clinical or equivalent experience in the pharmaceutical industry; managerial experience in hospital or pharmacy, and familiarity with clinical assessment is highly desirable.
Demonstrated computer literacy, particularly in the use and management of relational databases.
Ability to achieve personal objectives while meeting departmental standards of performance.
Ability to work under supervision in a matrix organization.
Good oral and written communication skills.
Fluency in spoken and written English; knowledge of additional language(s) an advantage.
Experience and skill with medical writing an advantage.
Ability, with supervision, to solve routine problems and to surface issues constructively.
Ability to make basic decisions with an understanding of the consequences.
Bachelor degree in a science-related field, pharmacy or nursing or equivalent, advanced degree an advantage.

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。

联系方式

  • Email:ChinaCPWTalent@Pfizer.com
  • 公司地址:1 (邮编:200000)