Head, Medical Safety Sciences, Patient Safety & Pharmacovigilance (PSPV) (Vice President)

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Job Description

OBJECTIVES/PURPOSE:

• Responsible for optimizing the timely detection of safety signals and assessment of the benefit-risk profile for products in clinical development and marketed from the Takeda portfolio through the application of robust expertise, standards and processes and innovative solutions in Signal Management, Risk Management & Benefit Risk, Medical Review and Aggregate Safety Reports in compliance with Pharmacovigilance regulatory requirements worldwide

• Provides a robust, patient-centered, science-based and data-driven subject matter expertise leveraging the use of digital and automated tools and systems

• Shares best practices, ensure adherence to Health authority’s regulations and inspection readiness at all times

• Supports and advocates the vision and mission of the PSPV as a member of the PSPV Leadership Team.

ACCOUNTABILITIES:

• Leads and ensures managerial oversight of PSPV functions that are accountable for the establishment and maintenance of standards for the timely detection of safety signals and assessment of the benefit-risk profile for products in clinical development and marketed from the Takeda portfolio through the application of robust expertise and innovative solutions in Medical Review, Signal Management, Risk Management & Benefit Risk, and Aggregate Safety Reports in compliance with Pharmacovigilance regulatory requirements worldwide

• Supports and advocates the vision and mission of Global Patient Safety & Pharmacovigilance (PSPV) as a member of the Global PSPV Leadership Team

• Establish cross-functional and trusted collaborations across PSPV, R&D and at enterprise level  

Risk Management & and Benefit Risk Center of Excellence:

• Oversees the PV Risk Management Center of Excellence, ensuring its continuous operational execution and excellence applying best practices in accordance to regulatory requirements and guidelines worldwide and in alignment with the PSPV governance and operating model

• Provided leadership in benefit-risk assessments, risk management plans, risk minimization (including REMS) and risk communications

• Develop comprehensive benefit-risk analyses, with the use of qualitative and quantitative methodologies, to ensure that benefit outweigh the risks

• Conduct qualitative and quantitative benefit risk assessments (including BRACT and BRAD deliverables)

• Develop risk management and risk minimization strategy

• Lead the developments of risk management plan, risk minimization measures and REMS programs

• Lead patient engagement activities such as aRMMs comprehension and usability testing

• OISI Coordinator to characterize/escalate potential Safety Signals to identify risks

• Manage the Orbit risk management tracking tool

• Ensure compliance and inspections/audit procedures/processes in reflect alignment with various regulatory authorities’ regulations

Signal Management & PV Safety Analytics:

• Establish a robust Signal Management process and elevate the role of Signal Management (from signal identification through to evaluation of risk) as an integral part of the drug development and marketing continuum. 

• Act as an integral leader to advance the use of digitalization/AI/ML/Hyper-automation

• Identify all available data sources, internal and external to Takeda, and associated safety analytics tools to develop a state-of-the-art approach to Safety Analytics

• Support innovation/tool development with both PSPV and R&D Training Teams

• Ensure compliance and inspections/audit procedures/processes in reflect alignment with various regulatory authorities’ regulations

Medical Review:

• Ensure that adverse events are evaluated accurately and comprehensively.

• Ensure clinical assessment to determine factors like the seriousness, causality, and expectedness of the adverse event in relation to the drug

• Ensure compliance and inspections/audit procedures/processes in reflect alignment with various regulatory authorities’ regulations

Aggregate Safety Reports:

• Consolidates all data and findings into comprehensive safety reports

• Responsible for creating of safety reports required by regulatory authorities to monitor and assess the safety profile of a drug

• Communication of the benefit-risk profile to all pertinent stakeholders and regulatory authorities

• Ensure compliance and inspections/audit procedures/processes in reflect alignment with various regulatory authorities’ regulations

Education & Competencies (Technical and Behavioral):

• Bachelors required. Post-graduate degree or equivalent with advanced degree preferred, MD, PhD, or PharmD

• Minimum 15 years in pharmaceutical experience

• Advanced knowledge of PV and global PV regulations

• Experience working in a multi-disciplinary environment (e.g., QA, Clinical, Regulatory), including working in international setting

• Experience working within a complex and matrix organization with demonstrated ability to work across functions and regions at all levels.

• Ability to collaborate and effectively influence various functional areas, partners, regions, and cultures. • Direct experience in the pharmaceutical industry or related field required

• Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus

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

• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.

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

Technical/Functional (Line) Expertise:

• Comprehensive understanding of the pharmaceutical industry and PV Compliance

• Management of People skills to apply Takeda Leadership Behaviors

Leadership:

• Demonstrated ability to work across functions, regions, and cultures

• Functional 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

• Provides vision and leadership guidance of teams and projects with engagement of cross-functional stakeholders and external experts

• 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

• Demonstrates leadership presence and confidence

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

• Invests time in helping others to enhance their skills and perform at a higher level

Job Description Decision-making and Autonomy:

Decision making responsibilities:

• Provides input to highly complex decisions that impact the functional area o 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 implemented swiftly to yield flawless execution

• Accountable for providing input to 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

• Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.

• Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner

• Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions

• Externally engaged as representative from Takeda to create partnerships with academia, sponsoring fellowship programs within the universities and schools while working together to integrate opportunities for students to learn about pharmacovigilance

• Internally interacts with leaders cross-functionally at TET-1 & 2 level and below to influence and ensure the benefit risk assessments of products during life cycle to lead and contribute to the success of clinical development, filings and support of marketing authorizations of Takeda products worldwide

Innovation:

• Forward thinking with the ability to recommend, influence and implement 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

• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.

• Role models respect and inclusion, creating a culture that fosters innovation

Complexity:

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

• Deep expertise required

• Ability to see and understand broader, enterprise level perspectively

• Operates in a highly matrix environment with rapid evolving medical scientific approaches and regulatory requirements worldwide

• Leads and operates with Patient, Trust, Reputation and Business (PTRB) values

Competencies and Skills:

• Integrity

• Ability to relate well to people and to motivate and empower others

• Insights required to work productively in global company and across multiple functions

• Communication with clarity and brevity

• Capacity to take initiative and work productively in a high-pressure environment

• Strong knowledge of business area and understanding of the proactive interactions necessary to achieve business goals and objectives

• Ability to lead meetings and teleconferences, both internally in Takeda as well as externally to technical and lay groups and public meetings

TRAVEL REQUIREMENTS:

• Local and international travel across Takeda sites will be required

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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