Manager, Inspection Management Lead

企業名

Pfizer

職種 エグゼクティブ/経営 - 管理職(その他)
業種 製薬メーカー 勤務地 アジア 日本 東京都

仕事内容 The Senior Manager/Manager*, Inspection Management Lead supports Pfizer as required by preparing for, organizing and leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor as appropriate).
*The level of this position, Senior Manager or Manager, will be determined by the candidate’s experience and qualifications – both levels are described throughout this job posting.
Senior Manager
The Senior Manager Inspection Management Lead supports Pfizer by (as required) preparing for, organizing and supporting/leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor, as appropriate) conducted by global Health Authorities/Regulatory Authorities (HAs/RAs), and pharmacovigilance audits conducted by license partners, as appropriate. In addition, the Senior Manager Inspection Management Lead coordinates Pfizer responses to such inspections. The Senior Manager Inspection Management Lead may also provide support for other RQA activities in the region including, but not limited to; quality investigations, external stakeholder engagement, and Quality Management System support. 企業について
（社風など） Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place. 勤務時間 To be defined 応募条件 BASIC QUALIFICATIONS

•Bachelor’s degree or equivalent experience is required. Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered
•At least 8 years of relevant experience in clinical or pharmacovigilance QA, or other clinical quality management/QC 日本就職role in biomedical science, clinical development, regulatory compliance
•Fluency in the English language (written and verbal) is a requirement for this position
•Experience evaluating and understanding quality standards or their application

PREFERRED QUALIFICATIONS

•Prior experience in organizations or with applications for continuous improvement or metrics trending highly desirable
•Ability to function autonomously in a matrix model and in a team environment
•Advanced project management experience with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities a plus 年収 経験と能力に基づく   

本页面招聘信息来源于网络公开渠道，旨在便利求职者。我们尊重版权，如有信息使用不当，请联系我们更正（services@hijob.jp）。求职时，请自行验证信息准确性。本平台不对信息错误或损失负责，建议用户谨慎对待。