Senior Director, PV Process Lead

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The Senior Director Pharmacovigilance (PV) Process Lead:

• Owns designated end-to-end (E2E) pharmacovigilance (PV) processes for critical cross-functional areas setting the strategy accountability and oversight to ensure consistent execution in alignment with regulatory requirements.
• Cultivates trusted enterprise-wide relationships with key stakeholders across Takeda (e.g. Regulatory Quality Assurance Global Development Operations Clinical Science Medical Affairs Commercial Local Operating Companies DD&T) demonstrating executive presence and strategic influence while serving as the central orchestrator to ensure strong PV oversight and performance identifying risks driving issue resolution and promoting alignment and decision-making among cross-functional stakeholders.
• Drives continuous process improvement operational excellence and efficiency by leveraging technology and AI-enabled capabilities to enable streamlined compliant and inspection ready E2E processes with clear roles and responsibilities.

By driving governance alignment and execution across critical cross-functional PV processes this role delivers enterprise-level impact. With strong partnerships and a continuous improvement and technology/digital mindset the PV Process Lead enables the organization to deliver on key priorities operational excellence and advance patient safety across the business globally.

The PV Process Lead is accountable for the strategy direction and implementation of end-to-end processes to ensure they are in line with health authority PV requirements and deliver on key priorities.

The PV Process Lead:

• Serves as the enterprise process owner and central orchestrator for E2E PV processes building and sustaining trusted relationships with senior cross-functional stakeholders driving alignment decision-making and accountability across the organization.
• Drives cross-functional governance and operational excellence by defining roles decision accountability and forums that enable collaboration transparency and effective execution.
• Owns the design procedural documentation implementation management and oversight of designated E2E PV processes with scope expanding to other E2E processes as needed.
• Develops authors maintains and approves procedural documents associated templates/forms training materials and other toolkits for designated E2E PV processes. Provides input to associated procedural documents owned by sub-functions in relation to designated E2E PV processes.
• Provides E2E PV oversight for designated processes by proactively identifying risks trends and gaps and ensuring timely escalation resolution and mitigation in line with regulatory expectations.
• Serves as the main point of contact for Quality Events CAPAs and Change Controls related to the designated processes and represents those E2E processes during audits and health authority inspections.
• Contributes to process impact assessments in response to changes in PV regulatory requirements identified through Takedas regulatory intelligence activities and oversees implementation of the necessary updates to ensure these processes comply with new regulatory requirements.
• Champions technology and AI-enabled capabilities to drive continuous process improvement operational excellence and efficiency by streamlining the E2E processes defining clear roles and responsibilities and ensuring that they are in-line with regulatory requirements to maintain inspection readiness at all time.
• Provides support and back-up for other designated E2E PV processes as needed to ensure continuity quality and timely execution.
• Performs other duties as requested by management.

The PV Process Lead has:

• Deep PV knowledge and subject matter expertise on designated E2E PV processes
• Deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines with extensive understanding of pharmacovigilance processes
• Comprehensive understanding of the pharmaceutical industry and PV compliance
• Good analytical/judgement and critical thinking capabilities to understand analyze synthesize and communicate
• Project management skills including ability to manage time and multiple priorities
• Enterprise-level leadership with the ability to inspire influence motivate and drive results
• Demonstrated ability to work across functions regions and cultures and capable of reconciling conflicting views into a cohesive path forward
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company
• Ability to distill complex issues and ideas down to simple comprehensible terms
• Cross-functional collaboration: able to synthetize diverse inputs from multiple constituents and stakeholders to drive innovative solutions
• Accountability for decision-making for the designated function
• Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
• Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions
• Forward thinking in exploring and leveraging technology and AI-enabled capabilities to drive continuous process improvement efficiency and operational excellence
• Ability to work in a global ecosystem (internal and external) with a high degree of complexity
• Deep expertise in the pharma industry and PV required
• Ability to see and understand broader enterprise-level perspective

The PV Process Lead:

• Is an excellent communicator able to persuasively and effectively convey both ideas and data verbally and in writing
• Embraces and demonstrates a diversity and inclusion mindset and role models of these behaviors for the organization
• Is designated as point of contact for audits and inspections pertaining to designated E2E PV processes
• Is accountable for designing and implementing vision and strategy for designated scope
• Effectively navigates the changing external and internal environment and leads others through change by creating an inspiring and engaging workplace
• Stay informed about novel tools and processes and be comfortable challenging the status quo to bring forward these innovative solutions
• Recognize the opportunity to improve the process to achieve business benefit. Identify and manage interdependence across processes

The following Education & Competencies are required:

• Bachelors degree or international equivalent required; Life Sciences preferred
• 10 years experience in the pharmaceutical industry with a focus on drug safety and pharmacovigilance
• Proven experience in a senior leadership capacity managing matrix teams and fostering strong partnerships and collaborations with cross-functional stakeholders at enterprise level.
• Strong strategic and critical thinking negotiation and influencing skills across all levels of the business.
• Excellent planning execution and communication skills with a drive to deliver results.
• Ability to collaborate and effectively influence various functional areas partners regions and cultures.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

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.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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EEO Statement

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