辉瑞(武汉)研究开发有限公司

一、公司简介

    辉瑞公司建于1849年，迄今已有160多年历史。总部位于美国纽约，是目前全球最大的以研发为基础的生物制药公司。辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。

二、招聘需求

岗位名称:

      药物安全评估员-Associate I, Safety Assessment

工作职责:

Position Purpose

- Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.

审核，准备，完成药物不良经历报告，帮助认识辉瑞产品的安全面貌，并符合法规报告要求。

Primary Responsibilities

- Provide professional evaluation to Individual Case Safety Report (ICSR) in Pfizer Safety Database, including but not limited the activities as follows.

在辉瑞安全数据库中，对ICSR做专业评估。包括但不仅限于以下内容。

- Identify reportable cases, evaluate cases in appropriate prioritization, and meet reporting timeline

明确需要提交的报告，合理安排优先秩序对报告进行评估，符合报告时限。

- Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; and etc.

对下述内容进行审核，排序，核对，评估和存档：事件，报告类别（有效性，严重性，已知性），特殊情况，产品投诉信息，等等。

- Write and edit the case narrative.

- Consistently apply regulatory requirements and Pfizer policies.

完全遵守法规要求和辉瑞政策。

任职资格:

Technical Skill Requirements

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

具有以下经验者优先考虑：药物警戒，临床实践，临床或科学性研究。但不是必须。

· Demonstrated computer literacy, particularly in the use and management of relational databases.

熟练运用计算机，特别是有使用相关数据库经验者。

· Excellent oral and written communication skills.

良好的口头和书面沟通能力。

· Fluency in spoken and written English.

流利英语口语和书写。

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

· Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.

科学相关领域本科及以上，药学，护理，或同等学历；医务工作资质者优先考虑。

· Ability, with supervision, to solve routine problems and to surface issues constructively.

能在指导下解决日常问题，并且建设性面对难题。

· Ability to make basic decisions with an understanding of the consequences.

能在理解事情结果的情况下独立做决定

岗位名称:

      药物安全专员 (DSU Platform)

工作职责:

1. Carry out case processing activities

2. Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments

3. Review case criteria to determine appropriate workflow for case processing

4. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately

5. Write and edit case narrative

6. Determine and perform appropriate case follow-up, including generation of follow-up requests

7. Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

8. Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation

9. Develop 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 database

10. Determine reportability of scheduled reports , ensuring adherence to regulatory requirements

11. Consistently apply regulatory requirements and Pfizer policies

12. Participate, as appropriate, in local, internal and external safety activities

任职资格:

1. Technical Skill Requirements

2. Experience in pharmacovigilance and/or data management preferred but not required

3. Experience and skill with medical writing an advantage

4. Demonstrated computer literacy

5. Experience in use and management of relational databases preferred

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

7. Health Care Professional or equivalent experience preferred

8. Ability, with supervision, to solve routine problems and to surface issues constructively

9. Ability to make basic decisions with an understanding of the consequences

10. Ability to achieve personal objectives while meeting departmental standards of performance

11. Ability to work under supervision in a matrix organization

12. Fluency in spoken and written English

岗位名称:

      药物安全专员-Safety Data Management Specialist

工作职责:

· Carry out case processing activities

· Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments

· Review case criteria to determine appropriate workflow for case processing

· Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately

· Write and edit case narrative

· Determine and perform appropriate case follow-up, including generation of follow-up requests

· Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

· Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation

· Develop 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 database

· Determine reportability of scheduled reports , ensuring adherence to regulatory requirements

· Consistently apply regulatory requirements and Pfizer policies

· Participate, as appropriate, in local, internal and external safety activities

任职资格:

Technical Skill Requirements

· Experience in pharmacovigilance and/or data management preferred but not required

· Experience and skill with medical writing an advantage

· Demonstrated computer literacy

· Experience in use and management of relational databases preferred

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

· Health Care Professional or equivalent experience preferred

· Ability, with supervision, to solve routine problems and to surface issues constructively

· Ability to make basic decisions with an understanding of the consequences

· Ability to achieve personal objectives while meeting departmental standards of performance

· Ability to work under supervision in a matrix organization

· Fluency in spoken and written English

岗位名称:

      Clinical Trial Associate (CTA)

工作职责:

•Provide protocol and ICD administrative support to global Clinical Operations Study Team Leads (COSTLs) and Clinical Research Operations Managers (CROMs), including but not limited reviewing the consistency of documents, prepare RighTrack II protocol outputs report, circulate and track the approval status.

•Request set up of study team SharePoint spaces, grant access to the team and update files in SharePoint for Inspection Readiness documents including team roster changes, , updating version dates etc.,  and uploading of meeting minutes and any documents to SharePoint as required.

•File documents to PTMF/ GDMS.

•Maintain Pfizer Trial Master File (PTMF) in accordance with ICH-GCP and SOPs.  Update the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner

•Assist team with the preparation of any documents upon request, including but not limited to vender oversight plan, correspondence with investigator sites and vendors, study specific manuals for the sites, etc.

•Track and update all information on an ongoing basis per request, including but not limited to site contact information, required site training attendance, vender information, patient recruitment, trial suppliers, payment schedule, Ariba orders, etc.

•Attend appropriate training programs and project teleconferences as applicable.

•Assist COSTLs/CROMs on preparing investigator meetings if required.

•Support and coordinate any activities as requested by COSTLs/ CROMs and as assigned within required timelines.

Preferred

•Knowledge of ICH GCP and local regulations

•Experience in management of clinical trial and/or regulatory documents

•Knowledge of application used in the clinical trials

薪资福利:

通讯/交通/住房补贴

带薪年假长

员工福利多

班车接送

500强外企，高大上的工作环境

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