Senior Product Manager Patient Safety Pharmacovigilance

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As the Senior Product Manager you will define and execute the vision strategy and delivery of technology solutions that enable global Patient Safety and Pharmacovigilance (PSPV) development functions. You will act as the system owner for clinical safety and PV systems overseeing end-to-end operations upgrades and AI/ML implementations to improve safety operation. You will own a portfolio of platforms and productssuch as Argus Veeva Safety Docs Empirica and supporting integrationsand drives innovation to accelerate safety submissions ensure compliance and enhance operational efficiency. You will develop and convey portfolio level strategy and vision in collaboration with stakeholders aligning with business goals and technology directions. Maintains and communicates the integrated portfolio product roadmap to ensure team alignment and delivery of value.

• Drive platform rationalization data quality and master data management strategies across Patient Safety and Pharmacovigilance (PSPV) functions.

• Oversee safety data trends signal detection and the preparation of high-quality safety responses for regulatory submissions and audits.

• Lead cross-functional product teams (product managers solution architects engineers data stewards and external vendors) using Agile or hybrid methodologies.

• Lead cross-functional teams (DDT Clinical Regulatory) to align safety operations with business goals.

• Maintain the Pharmacovigilance System Master File (PSMF) and ensure compliance with global regulatory guidelines.

• Oversee system implementation integration and enhancement projects ensuring delivery on time within budget and to quality standards.

• Ensure all systems meet regulatory requirements (21 CFR Part 11 GAMP 5 GDPR FDA/EMA guidelines).

• Manage and mentor a team of product managers business analysts and technical leads.

• Foster a culture of innovation collaboration and continuous improvement encouraging professional development and cross-functional learning.

• Strategic thinker with the ability to translate PSPV/Safety business needs into technology capabilities.

• Inspires trust and collaboration across business and IT teams.

• Strong knowledge of global regulations safety systems and regulatory compliance.

• Exceptional stakeholder management communication and influencing skills at the senior executive level.

• Demonstrated success in Agile product management technology strategy and vendor management.

• Experience with cloud-based platforms (Veeva Salesforce AWS Azure) and emerging technologies such as AI NLP and process automation.

• Collaborate effectively with Product Managers Business System Owners and key business stakeholders Solution Architecture and other stakeholders on a Ecosystem of Products Platforms Analytics and Microservices to give Takeda a modern footprint.

• Embeds with product teams as needed to ensure full transparency and no surprises keeping product stakeholders up to date with the latest on delivery status product risks and scope changes.

• Effective at conveying the portfolio vision and other messages requiring action in a way that brings people on board with the vision and builds their enthusiasm about fulfilling it

• When required to evangelize the vision into target communities or ecosystems is effective in representing the product or platform within that community in a way that ensures all ecosystem partners feel heard and well-served by the product vision.

• Masters degree in relevant field such as Computer Science Engineering Business.

• 10 years of IT leadership experience in digital product management or pharmaceutical safety often with a background in Agile methodologies.

• Deep expertise in Patient Safety and Pharmacovigilance (PSPV) and R&D technology ecosystems (e.g. Veeva Safety Docs Argus Empirica).

• Deep knowledge of pharmacovigilance principles drug safety regulations and Risk Evaluation and Mitigation Strategies (REMS/RMP)

• Proven track record of managing multi-million-dollar technology portfolios and delivering complex global programs.

• Experience with safety databases and AI/ML technologies.

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.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

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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