Head, Patient Safety & Pharmacovigilance (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 program management), Business Continuity plan, Partnerships and engagement for divestment activities, and business operations

• Ensure inspection readiness at all times of the PV Operations function globally

People and Culture:

• Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.

• Ensure global communication, social events across PSPV worldwide including Town Halls, PSPV department meetings and foster culture of community across PSPV globally 

Collaboration and Engagement:

• Serve as the point of contact and engage with functional leaders across R&D, Communications, Finance, HR, Global Digital Technology, Digital, Data and Technology groups, and Procurement.

Dimensions and Aspects:

Technical/Functional (Line) Expertise:

• Understanding of the pharmaceutical industry  

Leadership:

• Demonstrated ability to work across functions, regions and cultures

• Division level leadership with the ability to inspire, motivate and drive results

• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing

• Proven skills as an effective team player who can engender credibility and confidence within and outside the company

• Ability to distil complex issues and ideas down to simple comprehensible terms

• Executive leadership presence and confidence

• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

Decision-making and Autonomy:

• Broad decision-making responsibilities: Ability to make highly complex decisions that impact the enterprise. Accountable for decision making for designated function. Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions. Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution. 

• Accountable for designing and implementing vision and strategy for designated scope

Interaction:

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace

• Effectively represent Takeda in high-level negotiations with the ability to resolve conflict in a constructive manner

• Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions.

Innovation:

• Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation

• Comfortable challenging the status quo and bringing forward innovative solutions

• Ability to take risks implementing innovative solutions, accelerating time to market

Complexity:

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity

Skills and qualifications:

• PhD/MS/MBA

• 10+ years of relevant business experience in the pharmaceutical industry 

• 8+ years line or matrix management experience, with clear evidence of leadership skills

• Operational experience in pharmaceutical drug development with significant direct exposure to clinical development

• Senior management experience in pharmaceutical industry and/or clinical research, biotech or related industries or related field, influencing senior-level management and key stakeholders

• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables

• Health care business acumen with a comprehensive understanding of the pharmaceutical industry

Accountabilities:

• As strategic partner to the Head of PSPV, define PSPV leadership focus and shape PSPV objectives, KPIs, and MRP (Mid-Range Plan) financial goals

• Effectively collaborates with senior leaders and functions to ensure alignment and integration of strategic initiatives.

• Oversee PSPV Communications: drive transparency throughout PSPV, facilitate connectivity, enable within-function and cross-functional reporting, drive strategy and implementation of external and internal communications

• Oversee PSPV Portfolio activities: deliver portfolio analytics, manage governance review, facilitate tracking and project management

• Oversee PSPV Operations: drive continuous operational improvement across PSPV, co-lead financial planning with Finance, co-lead outsourcing strategy with Procurement, ensure quality and compliance, support PSPV colleagues’ professional development

• Define holistic view of PSPV activities to support PSPV LT portfolio prioritization and inform stakeholders outside PSPV (e.g., TAUs, CEI, Pharm Sci)

• Manage the overall PSPV workflow, liaising within PSPV and beyond (e.g., DSI, Legal, Finance, HR, Procurement, Quality, Facilities, EHS, IT) to ensure that deliverables are provided on schedule, surface and resolve bottlenecks, and modify business processes to meet Takeda’s evolving needs

• Promote a culture of innovation, collaboration, and appropriate risk-taking through personal example, mentorship, and accomplishments.

This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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