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 analyti