Date posted:  May 1, 2025
City:  Tokyo
Country/Region:  JP
Type of Contract:  Full-time Employment / Unlimited
Job Requisition ID:  8559

PV specialist

.

About Servier    

Servier Group is a French pharmaceutical company that provides innovative therapies to millions of patients across 150 countries, with the support of 22,000 employees. We proudly hold the title of "Best Place to Work," embodying innovation and independence. Our goal is to leave a world for future generations where quality healthcare is accessible to everyone.  

Entirely independent, Servier reinvests 25% of its total turnover (excluding generics) in Research and Development, a driver of innovation. The priority objective is to reach a profit allowing Servier to maintain this level of investment guaranteeing innovation, independence and future sustainability. 

 

Servier focuses on five therapeutic areas of research: cancers, cardiovascular diseases, diabetes, immuno-inflammatory diseases and neuropsychiatric diseases. Currently, Servier has more than 39 clinical programs including 17 new molecular entities at different stages of clinical development. 

 

The ambitions for 2025 are as follows:  

  • Launch one new molecular entity every three years 
  • Become a key player in oncology 
  • Reach €6.5 Bn in consolidated revenue 
  • Increase EBITDA to €1.3 Bn to sustain heavy investment in development. 

   

All employees are driven by shared values and guided by a common vision, sharing a passion for entrepreneurship, and committed to therapeutic progress to serve patient needs.     

 

ROLE & RESPONSIBILITIES:  

  • following pharmacovigilance activities: 
  • Preparation of various periodic reports (e.g. J-PSUR, J-DSUR) 
  • Implementing and revision of the Risk Management Plan (J-RMP) 
  • Drafting and implementation of safety assurance measures 
  • Preparation of re-examination 
  • Negotiations with other departments, partner companies, HQ, CRO, and regulators 
  • Oversight the partner company and CRO 
  • Safety assessment of safety information such as domestic and overseas case information, literature information, and manage collection, pre-evaluation, reporting and follow-up of them. 
  • Ensuring the compliance with laws and regulations in Japan, the United States, and Europe, and SOPs 
  • Response to Inspection and audit of domestic and overseas internal and regulatory authorities        

 

YOUR PROFILE:  

Advanced degree in business, medical or life-science 

 

Job Expertise:  

  • Minimum 3 years work experience in pharmacovigilance for drug in development or drug reexamination.  
  • Experienced personnel in charge of safety management with other departments, partners, HQs, CROs or regulatory authorities. 
  • Experienced in preparing various periodic reports  
  • Experienced in preparing risk management plans 

 

Skills/Knowledge Required:  

  • Knowledge of GPSP, GVP, GCP and related laws and regulations. 
  • Communication and project management skills. 
  • Leadership in difficult situations. 
  • Business level English skills (reading, writing and speaking)  

  

Qualifications:  

  • Pharmacist (preferred) 

 

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

 

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.