Pharmacovigilance Director

Tokyo 23 Wards Permanent Foreign Multinational
  • Work at an Industry Leading Global Contract Research Organization
  • Contribute the Safety and Wellness of Patients Globally

About Our Client

  • Leading global CRO with an expanding presence in APAC
  • High speciality in Oncology, Rare Disease and CNS areas
  • Focused largely on ICCC studies for US Biotech companies without operations in Japan

Job Description

  • Oversees financial performance of assigned units; develops and manages top and bottom line revenue growth and expense budgets for Safety and Pharmacovigilance.
  • Provides operational and strategic leadership for Safety and Pharmacovigilance to achieve the Company's mission, creating value for customers.
  • Evaluates and measures performance metrics and improves processes, as needed.
  • Directs the Safety and Pharmacovigilance associates to achieve on-time quality customer deliverables, contractual project requirements, utilization goals, and profitable results.
  • Identifies and develops associates to carry out required functions. Provides professional development and growth opportunities as appropriate. Is accountable for appropriate escalation and resolution of issues within the department/business unit.
  • Supports business development on project proposals and approval of Safety and Pharmacovigilance budgets.
  • Assists in the creation, development and nurturing of key strategic customer relationships; develops strong relationships with current and prospective customers to generate new and/or add-on business.
  • Effectively leads and encourages collaboration and work sharing between offices to create a unified global Safety and Pharmacovigilance team.
  • Ensures best practices and processes are followed globally.
  • Maintains current professional knowledge and expertise in fields of Safety and Pharmacovigilance to serve as a basis for providing "value added" expanded company services to all appropriate customers.
  • Line management responsibilities for associates. Approves course of action on salary administration, interviews, hiring, terminations, professional development, performance appraisals, job descriptions and training.
  • Implements quantifiable performance standards to facilitate improvement of global efficiencies and operational excellence.
  • Participates in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
  • Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes.
  • Participates, defines, and approves process development and improvement of departmental functions and technology.
  • Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings.
  • Provides oversight and governance between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
  • Maintains understanding and ensures compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study plans and the drug development process.
  • Participates in audits/inspections and ensures inspection readiness.
  • Participates in quality investigations and ensures implementation of corrective and preventive actions.
  • Performs other work related duties as assigned.
  • Moderate travel may be required.

The Successful Applicant

  • Extensive management experience in pharmacovigilance case processing (data entry, triage, evaluation, QC, submission)

  • Leadership experience in pharmacovigilance. (e.g. OJT, SOP renewal, system update, managing timeline and quality)

  • Fluent Japanese language proficiency and upper business level English
  • Prior experience in global CRO preferable

What's on Offer

  • Opportunity to build leadership skills within a management position
  • Opportunity to work on a large number of diverse projects to develop a broad range of IMPs
  • Work on global studies at an industry leading international company
  • Flexible working hours
  • Flat company culture
  • Highly competitive salary
Ed Marsden
Quote job ref
Phone number
+813 6832 8981

Job summary

Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
Company Type