This position leads Business Excellence and Project Management Office (BE/PMO), contributing to the strategic planning and implementation of improvement initiatives and special projects in DSE CSPV, and also contributes to global CSPV projects and improvement initiatives. This position collaborates within global PV and CS teams, and interdepartmental teams and interacts with CROs, vendors, and partners as the PM driver/facilitator. This level is responsible for resolving escalated issues, identifying opportunities, and designing business solutions that meet ongoing and future anticipated CSPV’s needs.
This position also supports the DSE RH with matters regarding budget, tracking of team goals and objectives, and additional Unit Planning related activities.

PERSONAL SKILLS AND PROFESSIONAL EXPERIENCE:

• Bachelor’s or Master’s degree in Nursing, Pharmacy, Life Sciences, Healthcare, or a related field
• 5 or more years experience of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products
• 3 or more years experience of business process analysis/design experience and/or project management
• PMI’s PMP certification preferred Prosci or ACMP certification preferred Six Sigma certification preferred
• Creates a culture of compliance for the function: works cross-functionally to identify risks and trends for the function.
• Owns operational strategic plans, defines and manages priorities within the function and drives implementation.
• Identifies issues independently, thoroughly understands cause of issues, recognizes functional and global impact, and oversees implementation of solutions.
• Interfaces, collaborates and negotiates with internal and external stakeholders to ensure successful results and resolution to complex issues.
• Drives timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional priorities.
• Applies PV knowledge to promote efficiency and compliance for assigned projects within the function with both internal and external stakeholders.
• Knowledge of applicable global pharmaceutical legislation, specifically FDA, EMA and ICH safety reporting regulations, Good Clinical Practices, Good Vigilance Practices, patient privacy laws and other applicable local regulations.
• Ability to define and monitor KPIs to achieve optimal performance
• Excellent communication skills, including the ability to extract and make transparent key information from different fields to prepare decisions by CSPV leadership
• Ability to travel up to 5%

• Business Excellence:
• Help to identify the business areas in greatest need of process optimization using client needs, best practices, and benchmark performance measures.
• Understand and support DSE CSPV, global CSPV initiatives, and DSE leadership vision.
• Support translation of strategic objectives into executable actions.
• Direct and coordinate the gathering of business requirements through a variety of techniques (e.g., workshops, work sessions and interviews).
• Facilitate process mapping and design workshops.
• Review high-level and detailed business process designs for scope adherence.
• Review and present gap analysis highlighting current state, future state, CSPV needs, and best practices.
• Facilitate discussions to identify root causes for operational and quality issues. Identify performance metrics for current-state business processes.
• Establish performance goals for future-state business processes based on CSPV needs, best practices, and benchmark performance measures.
• Conduct impact analysis of process redesign on existing organization roles, principles, and technical infrastructure and guide others to understand the impact.
• Project Management:
• Responsible for planning, managing, and coordinating projects within DSE CSPV and global CSPV with respective SMEs to ensure deliverables in a timely and as intended and meeting quality standards.
• Support SMEs in preparation of business requirements and generate documentation for Request for Information (RFI) and Request for Proposal (RFP) documents, evaluation of Evaluate RFI and RFP responses for an optimal solution; Monitor and manage scope change requests; with periodic progress reports against budget and time frames to CSPV Leadership.
• Facilitate in prioritization of projects/initiatives to optimize CSPV effectiveness and quality both regionally and globally.
• Support RH and EU/UK QPPV oversight of activities, goals/objectives, and budget.
• Develops goals, continued compliance and strategy for process improvement initiatives, and business continuity with senior management team.
• Develop tracking measures and implementation strategies to ensure that oversight of PV activities are being carried out
• Support budget planning and monitoring activities
• Work closely with CSPV Leadership to drive projects toward achieving the intended business results and plan for anticipated growth with expanded and evolving scope of activities.
• Effectively communicate with key global and cross-functional stakeholders to identify interdependencies and collaboration opportunities