Senior Product Manager - Patient Safety Pharmacovigilance
Listed on 2026-07-24
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IT/Tech
IT Project Manager
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Job DescriptionTitle:
Senior Product Manager - Patient Safety Pharmacovigilance
Location:
Cambridge, MA (Hybrid)
About the role:
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 products—such as Argus, Veeva Safety Docs, Empirica and supporting integrations—and 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 an 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.
- Master’s 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…
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