Head of PSPV Strategy & Operations Office

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Job Description

How you will contribute:

• Senior advisor to the Head, Patient Safety & Pharmacovigilance (PSPV) to develop, drive and implement the overall strategic direction of the organization, ensuring alignment with Takeda's mission and objectives.

• Leads the PV Operations function to drive for transformative and innovative operational excellence and compliance always ensuring inspection readiness

• Oversees the strategy and operational excellence of the Takeda Safety Board Office (TSBO) and Global PV Educational functions 

• Works with the PSPV Leadership Team to provide direction, solve problems, mediates disputes amongst the organization to ensure alignment and overall direction.

• Aligns PSPV implementation strategies and plans with other functions within R&D and other key divisional or corporate initiatives. Responsible for KPI and FY goals- management, budget and resources, and internal and external functional communications

Accountabilities:

Strategic Direction:

• Develops plans to ensure execution of PSPV strategy, projects and commitments which drive delivery of strategic outcomes and connectivity across R&D and the broader Takeda organization and establish a roadmap for achieving them.

• Serve as a strategic thought partner to the Head of PSPV and PSPV Leadership Team regarding problems, current and future initiatives, strategies, project management and budgets. Looks across PSPV functions to identify synergies and interdependencies to ensure optimal working model across all sites/functions.

PV Operations:

• Leads and drives strategy for the Global PV Operations function in compliance with PV regulations and guidelines requirements worldwide always ensuring inspection readiness

• Ensure transformative and innovative operational excellence and compliance of the PV Operations function in alignment with DD&T strategy at R&D and enterprise level

• Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice

PV Excellence:

• Lead and facilitate development of PSPV functional visions and strategies and execute PSPV’s Strategy & Operations support for all global PSPV activities. Establish over-arching capabilities within PSPV and ensure they work together effectively, with clear accountability and delivery.

• Support meetings, tracking of activities and deliverables of the PSPV Leadership Team

• Oversee the operational excellence and tracking of the Takeda Safety Board Office 

• Oversee the strategy and operational excellence of the Global PV educational function enabling internal and external collaborations for PV education

• Ensures robust development, oversight and measure of strategy-related activities and deliverables and drives organizational planning and implementation activities including project management across PSPV to increase interdepartmental efficiencies related to budget and resources

Performance and Value:

• Ensure optimal expenditure of budget and resources and assess the "value" generated across the organization and Lead PSPV budget and resourcing activities with Finance to ensure optimal operating environment; this includes coordination of the funding for PSPV initiatives globally.

• Be accountable for core deliverables in strategy development, PSPV-wide initiatives, projects and activities (including communication, change management, and progr