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■PV Operation Manager Tokyo Japan,  

Sanofi (company)

Posted on : 08 March 2019

Project Description

・management of book-in activity with safety Data Management system.
・exchanging safety information with domestic and overseas
affiliates/stakeholders in Compliance with sops/sdea.
・reporting safety information to japanese regulatory authority with safety Data Management system.
・management and improve of vendors’ activity such as implementation activities, Training and capa.
・conducting impact Analysis for the change of the internal process /regulation and prepare the plan for the implement and take appropriate actions for the implementation.
・communicating smoothly with internal and external stakeholder and regulatory authorities.
・corresponding to nspections/audits from regulatory authorities/third parties.

【expected personalities】

・act as proactive
・take forward-looking stance and take the Leadership for issues
・cooperative personality

【expected qualifications, skill and experiences】

・5 or more years of Pharmacovigilance
・experience of management (if excellent experience as a Leader instead of management experience)
・sufficient knowledge of japanese  Pharmacovigilance regulation
・experience corresponding to the inspections by regulatory authorities
・experience of using safety information management system
・experience of Communication with overseas affiliates/stakeholders

English skill:comunication with global affiliates smoothly 
・background of science or Pharmacy
・excellent knowledge of safety information management system (more preferable for argus)




1) outsorce vendorに必要な教育の実施、業務管理、capaも含めた業務改善を遂行すること
2) 社内プロセスの変更/規制変更に対して必要なimpact analysisを行い、適切なプロセスの変更を実施すること







at sanofi diversity and inclusion is foundational to how we operate and embedded in our core values. we recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. we respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.


Tokyo, Japan

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