job offers of fujitsu at Europe Language Jobs

Pharmaceutical Team Leader

  • Individuals in this role supervise and quality control the compilation, maintenanceand updating of Regulatory Documentation and associated data in the client
  • Regulatory database system, documentation version control
  • Optimizing utilization, and effective Resource Allocation planning for the team
  • 100% compliance for work allocation
  • Good Team Management (Indicated through good Skip level feedback and no major escalations)
  • Ensure adherence to Cognizant and Client SOPs (Standard Operating Procedure)
  • Responsible for regular FMEA update
  • Complete all mandatory training courses as applicable
  • Effective risk management and issue handling by conducting daily huddle and escalating them on time to time
  • Provides support to the following processes:
    • EVMPD
    • Global Labeling
    • Submission Management
    • Compliance Data Management
  • Develops and mentors the associate by providing expertise applicable to their region of responsibility
  • Leads a delivery team, manages people.
  • Coordinates and triages all work activity.
  • Provides input into BI processes and software to Engagement Manager for communication back to BI.
  • QCs work through spot checks on a regular basis.
  • Understands Client expectations.
  • Ensures training completion and compliance to applicable CTS and BI "Quality Management System"
  • To ensure that the PGTP is compliant as per the Project requirements & SOP for Training at Cognizant Intuitive Operation & Automation (IOA)
  • To ensure team is in compliance to applicable CTS and BI "Quality Management System"
  • Bachelor degree in life sciences/pharmacy with 3-5 years of experience in Regulatory
  • Affairs, PV Data handling
  • Electronic Regulatory Database usage
  • English (required actual work execution)
  • Good verbal and written communication skills
  • Knowledge of product life cycle management from regulatory perspective would be an added advantage

Pharmaceutical Team Leader