IQVIA Services/ Pharmacovigilance/ PV Systems SME - (1807421) in Tokyo, JP at IQVIA™

Date Posted: 6/21/2018

Job Snapshot

  • Employee Type:
  • Location:
    Tokyo, JP
  • Experience:
    2 to 3 years
  • Date Posted:
  • Job ID:

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Operations Management
• Ensure system compliance activities to ensure quality and timely processing of business performance information.
• Responsible for LS systems implementation across Japan, including requirement gathering, scoping for new projects, implementing modules & version for new projects and interaction with the development team.
• Responsible for user support and maintenance of LS systems

Business Value Additions
• Providing advice to LS system users for smooth operations
• Assist with the development and continual improvement of LS Systems
• As System SME, liaise with internal and external departments and across project teams for system-related process management solutions.

Responsible for LS Systems implementation, customer support and maintenance
• Provide solution/support for incidents across LS Systems
• Maintain LS Systems along with requests or regular bases
• Liaise between development team/LS Systems team and Japan Safety Operations
• Act as business SME from operations for implementation of LS Systems: including requirement gathering, scoping for new projects, implementing modules & version for new projects and interaction with the development team.
• Assist in the SDLC process of IT as required for the operations team, this includes participating in requirement gathering, verifying the design, setting up the system/enterprise, and conducting/supporting User Acceptance Testing (UAT) as required.
• Assist with assuring system compliance to CFR 21 part 11 and PMDA regulations/guidelines.
• Designing and documenting process maps and system flow diagrams.
• Assist with process improvement implementation as System SME when identified through project audits or by management.

Participate and initiate in continuous improvement of all departmental Systems and processes.
• Providing recommendation as System SME on process improvement solutions.
• Work closely with senior Management to communicate process improvement strategies.
• Define and communicate the benefit, costs, scope, approach and risks associated with new initiative.

Coordinate and liaise with internal and external departments, sponsors and across project teams for Performance management process metric deployment.
• Provide systems training for internal and external clients if necessary.
• Serve as liaison between PhV, Information Technology (IT) for Lifecycle safety Japan system needs.

Perform other duties as directed by lifecycle Management.

Job Requirements

A Bachelor’s degree in Life Sciences, computer science, or statistics; additional experience 2-3 years in pharmaceutical and or Clinical research environment, preferably in Drug Safety; Lifecycle Safety Systems is essential.
Working knowledge of Lifecycle Safety Systems (especially Argus) and Regulations are required. Strong business process analysis and process re-designing skills, Strong problem-solving skills and analytical skills are required.
Excellent conceptual, organizational and communication skills are essential.

• Knowledge of LS Systems
• Proficiency in MS Office applications and email based systems
• Proficiency in any other technology will be a valuable addition.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: 1807421