Director, Safety and PV Systems – Innovation, AI

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Own the roadmap and delivery of end-to-end SPVG technology solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics • Lead cross-functional execution with internal teams and external vendors/SIs; establish governance, SLAs/KPIs, and validated deployments • Chair innovation councils with customers and partners; convert problem statements into pilots/PoCs and scale proven patterns into offerings • Serve as solution lead on RFIs/RFPs, including reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses • Publish points of view, present at conferences/webinars, brief executives, and lead demos, workshops, and innovation sessions • Manage a small senior team, including mentoring, portfolio planning, resourcing, budgets, and benefits realization • Embed risk-based quality, privacy, and security by design in partnership with QA/Compliance and Data Privacy • Design and build minimally viable AI/ML prototypes and proof of concepts, including LLM-based agents and automation solutions • Develop or use connectors and integrations between AI tools and PV systems • Translate PV operational challenges into working demos to validate feasibility and business value • Partner with engineering teams to transition POCs into scalable solutions • Design and optimize prompt frameworks and establish prompt and accuracy governance • Refine AI outputs through testing, feedback loops, and performance monitoring • Support AI model validation, monitoring, explainability, and risk management • Lead and mentor AI/PV specialists

🎯 Requirements

• Experience and deep expertise in pharmacovigilance systems and technology solutions • Knowledge of case intake/processing, signal management, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics • Experience with governance, SLAs/KPIs, validated deployments, CSV, 21 CFR Part 11, EU Annex 11, and GAMP 5 • Experience leading cross-functional teams and external vendors/system integrators • Experience with RFIs/RFPs, reference architectures, delivery models, estimation, commercial constructs, and bid defenses • Knowledge of AI/NLP/RPA, data platforms, cloud, real-world data, and advanced analytics • Experience designing and building AI/ML prototypes, LLM-based agents, and automation solutions • Experience with OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms • Experience developing connectors and integrations using APIs, data pipelines, or middleware • Experience with prompt engineering, prompt governance, AI output testing, model validation, monitoring, explainability, and risk management • Leadership and mentoring experience • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Diverse career paths and employment opportunities