Countries & Regions Operational Excellence Leader

Major Activities 

• Represent Countries and Regions team in assigned PV related process optimization projects, metric design, and transition projects (e.g. acquisitions and divestments)
• Review procedural documents and guidance documents where Countries & Regions team is a key stakeholder
• Conduct or assist global risk assessment of assigned PV targets for audit or self-assessment in support to Countries and Regions Global Head
• Evaluate resources and headcounts impact of proposed projects and processes impacting Countries & Regions Team, based on figures collected from COs
• Work in collaboration with COs and other functions to perform CO compliance metrics trend analyses, generate knowledge and mitigate any identified risks and/or presentation to Operational Metrics & Risk Committee
• Participates and supports Regional Heads on projects related to Country Patient Safety processes and to CO outsourcing at Regional/Global level, when needed
• Act as system administrator for the Patient Safety Countries & Regions SharePoint, and the Vigilance Agreements Repository for local agreements

Team Player:

• Reliable, constructive communication skills, good listening skills, willing to share information, willing to cooperate and help, flexible.

Key Performance Indicators 

• Initiate and propose new and simplified processes for Countries & Regions
• Alignment with global and optimization of PV processes and resources
• Successful and timely implementation of projects and initiatives
• Quality and timely communications to COs of PV strategies and plans
• Problem-solving attitude demonstrated when proposing solutions
• No significant audit/inspection findings in area of responsibilities
• Internal and external customer satisfaction

Job Dimensions 

Number of associates:

No direct report

No indirect report

Financial responsibility:

(Budget, cost, sales, etc.)

None

Impact on the organization:                              

Critical, a significant compliance failure could result in an enforced cessation of business and the strategic development of pharmacovigilance capabilities is critical to future business success.

Ideal Background 

Education and/or professional experience:

Minimum: A Sciences degree (for graduates) or equivalent qualification with over 5 years of work experience in pharmacovigilance or drug development.

Languages:                

Fluent English (oral and written)

Knowledge of other languages desirable

Experience / Professional Requirements:          

• Knowledge of Pharmacovigilance regulations, processes and disciplines.
• Knowledge of Pharmacovigilance IT applications
• Capable of managing multiple projects
• Able to work independently and manage multiple tasks with prioritizing ability
• Well-organized, excellent time management with respect to priorities and self-management
• Strong interpersonal skills and expert team player with demonstrated ability to build collaborative cross functional relationships.
• Strong verbal and expert written communication skills