Pharmacovigilance Onsite Project Manager | Japan Jobs | Fidel Consulting KK

Pharmacovigilance Onsite Project Manager

Job Id : 6025
Posted : 2024-04-16
Industry : Information Technology and Services
Employment Type : Full Time, Permanent
Required Skills : JapaneseN, English2, Pharmaceutical
City : Tokyo or Osaka-Shi
State : Tokyo or Osaka
Country : Japan
Annual Salary : ¥10,000,000 ~ ¥12,000,000

Job Description

Position Name: Pharmacovigilance Onsite Project Manager


  • Operation details:
  • Ensure from onsite/offsite location a smooth execution of all Pharmacovigilance (PV) activities performed Including delivery timeline management and quality control.
  • Ensure smooth communication between client and onsite, global team.
  • Be the preferred point of contact of the client for all Pharmacovigilance issues
  • Across functions, identify trends and opportunities for improvements. Facilitate sharing of learning across geographies
  • Provide guidance and supervision on process and delivery to the PV teams (offshore, global team)
  • Ensure that all client requests are completed on time, as per the deadline. Clarify any confusion in Client updates when some information is unclear.


  • Knowledge of pharmacovigilance (3 years or more, individual case triage or QC experience) ⇒Case processing experience using PV data system
  • Knowledge of Pharmaceutical Affairs Law, GVP/GPSP Ministerial Ordinance, and related operations
  • Thorough expertise in processing pharmacovigilance activities (Quality control, ICSR management, specific reports)
  • Team management experience of PV Case processing
  • Training experience for members as leader ⇒Communication skills that are easy to understand and can convey things logically to others
  • Experienced handling for clients, such as requests and opinions from clients, etc ⇒the level of responding to client inquiries about cases Required
  • Languages: Native level Japanese, Business level English

Preferred Qualification

  • Project management experience of PV Case processing
  • Rigor and relationship skills
  • Should be able to identify risks and issues and come up with possible mitigations
  • Familiar with handling high volumes of data and figures
  • Good team management skills and communication skills. Strong learning ability

Company Description 

One of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. 
Their unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. 
Headquartered in the U.S., this company is one of the Fortune 500 companies and is consistently listed among the most admired companies in the world.

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Indoor smoking
Designated smoking area

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