職位描述
該職位還未進(jìn)行加V認(rèn)證,請仔細(xì)了解后再進(jìn)行投遞!
工作職責(zé):Position PurposeReview, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reportsPrimary Responsibilities Carry out case processing activitiesReview, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.? Process cases based on these assessmentsReview case criteria to determine appropriate workflow for case processingAssess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriatelyWrite and edit case narrativeDetermine and perform appropriate case follow-up, including generation of follow-up requestsReview processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenariosLiaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliationDevelop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety databaseDetermine reportability of scheduled reports , ensuring adherence to regulatory requirementsConsistently apply regulatory requirements and Pfizer policiesParticipate, as appropriate, in local, internal and external safety activities任職資格:Technical Skill RequirementsExperience in pharmacovigilance and/or data management preferred but not requiredExperience and skill with medical writing an advantageDemonstrated computer literacyExperience in use and management of relational databases preferredQualifications (i.e., preferred education, experience, attributes)Health Care Professional or equivalent experience preferredAbility, with supervision, to solve routine problems and to surface issues constructivelyAbility to make basic decisions with an understanding of the consequencesAbility to achieve personal objectives while meeting departmental standards of performanceAbility to work under supervision in a matrix organizationFluency in spoken and written English
職能類別:藥物警戒專員
本職位優(yōu)先軍人。

工作地點(diǎn)
地址:武漢硚口區(qū)武漢-硚口區(qū)


職位發(fā)布者
HR
輝瑞(中國)研究開發(fā)有限公司

-
制藥·生物工程
-
1000人以上
-
中外合資(合資·合作)
-
浦東科苑路88號上海德國中心2幢501-533室
相似職位
-
采購內(nèi)勤文員 面議浦口區(qū) 應(yīng)屆畢業(yè)生 不限南京交韻汽車科技有限公司
-
市場廣培生 10000-15000元浦口區(qū) 應(yīng)屆畢業(yè)生 本科中國平安人壽保險股份有限公司江蘇分公司
-
施工員 5000-8000元浦口區(qū) 應(yīng)屆畢業(yè)生 大專江蘇東道交通科技集團(tuán)有限公司
-
客戶開發(fā)專員 面議浦口區(qū) 應(yīng)屆畢業(yè)生 不限焦點(diǎn)教育科技有限公司
-
資深售前工程師/顧問(自控方向) 15000-25000元浦口區(qū) 應(yīng)屆畢業(yè)生 本科南京亞派科技股份有限公司
-
海外技術(shù)支持(科研服務(wù)) 12000-18000元浦口區(qū) 應(yīng)屆畢業(yè)生 碩士上海派森諾生物科技股份有限公司