更新于 12月6日

WRDC-PSSR-Associate I, Safety Assessment

面議
  • 武漢洪山區(qū)
  • 經(jīng)驗不限
  • 本科
  • 全職
  • 招1人

職位描述

藥企

Primary Responsibilities

  • Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
  • Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.
  • Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
  • Review case criteria to determine the appropriate workflow for case processing.
  • Write and edit the case narrative.
  • Generate reports, ensuring adherence to regulatory compliance timelines.
  • Determine appropriate case follow-up, requesting follow-up letters when appropriate.
  • Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
  • Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.
  • Consistently apply regulatory requirements and Pfizer policies.

Technical Skill Requirements

  • Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.
  • 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.
  • Excellent 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.

Qualifications (i.e., preferred education, experience, attributes)

  • Ability, with supervision, to solve routine problems and to surface issues constructively.
  • Ability to make basic decisions with an understanding of the consequences.
  • Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

#LI-PFE

工作地點

光谷生物城

職位發(fā)布者

劉一飛/RODA

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輝瑞公司(Pfizer Inc.)創(chuàng)建于1849年,總部位于美國紐約,是一家以科學(xué)為基礎(chǔ)的、創(chuàng)新的、以患者為先的生物制藥公司。輝瑞的使命是“為患者帶來改變其生活的突破創(chuàng)新”。在輝瑞,我們通過科學(xué)和全球資源為人們提供治療方案,以延長其生命,顯著改善其生活。在醫(yī)療衛(wèi)生產(chǎn)品的探索、研發(fā)和生產(chǎn)過程中,輝瑞始終致力于奉行嚴格的質(zhì)量、安全和價值標準。我們在全球的產(chǎn)品組合包括創(chuàng)新藥品和疫苗。每天,輝瑞在發(fā)達和新興市場的員工都在推進人類健康,推動疾病的預(yù)防、治療和治愈,以應(yīng)對挑戰(zhàn)我們這個時代的頑疾。輝瑞還與醫(yī)療衛(wèi)生服務(wù)方、政府和社區(qū)合作,支持并促進世界各地的人們能夠獲得更為可靠和可承付的醫(yī)療衛(wèi)生服務(wù)。這與輝瑞作為一家全球卓越的創(chuàng)新生物制藥公司的責任是一致的。170余年來,輝瑞一直致力于為所有依賴我們的人帶來改變。輝瑞于1989年進入中國市場。扎根中國30余年,輝瑞已成為在華主要的外資制藥公司之一。2021年是輝瑞新征程的開始。迄今已有170余年歷史的輝瑞正在邁入全新時代,成為一家以科學(xué)為基礎(chǔ)的、創(chuàng)新的、以患者為先的生物制藥公司。目前輝瑞在中國業(yè)務(wù)覆蓋全國300余個城市,累計投資超過15億美元,并設(shè)立了1家先進的生產(chǎn)設(shè)施,2個研發(fā)中心(分別位于上海張江高科技園區(qū)和武漢光谷),在華有近7,000名員工分布于業(yè)務(wù)、研發(fā)和生產(chǎn)等領(lǐng)域。輝瑞在華上市了五大領(lǐng)域的高品質(zhì)創(chuàng)新產(chǎn)品,包括腫瘤、疫苗、抗感染、炎癥與免疫、罕見病等多個領(lǐng)域的處方藥和疫苗,強大完善的產(chǎn)品線旨在滿足生命各階段的健康需求。
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