Director, Safety and PV Systems (Innovation & AI)

About the Role

This is a hands-on technical and strategic leadership position responsible for building, delivering, and scaling technology and AI-enabled Safety/Pharmacovigilance (PV) solutions for internal Syneos Health PVG operations and customers. The role orchestrates a partner ecosystem (internal IT, SaaS providers, systems integrators), leads solutioning for RFIs/RFPs and bid defenses, convenes innovation councils with customers, and represents Syneos Health as a visible thought leader in PV technology. This position combines expertise in PV systems and processes with applied AI/ML capabilities to drive innovation, efficiency, and compliant transformation.

Responsibilities

• 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—balancing speed, compliance, and value.
• Lead cross-functional execution with internal teams and external vendors/SIs; establish governance, SLAs/KPIs, and validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5).
• Chair innovation councils with customers and partners; convert problem statements into pilots/PoCs with clear success criteria and scale proven patterns into offerings.
• Serve as solution lead on RFIs/RFPs: reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses.
• Publish points of view, present at conferences/webinars, and brief executives on the PV tech landscape (AI/NLP/RPA, data platforms, cloud, real-world data, advanced analytics). Lead live demos, workshops, and innovation sessions.
• Manage a small, senior team: mentor staff; drive portfolio planning, resourcing, budgets, and benefits realization.
• Embed risk-based quality, privacy, and security by design; partner closely with QA/Compliance and Data Privacy to ensure all solutions meet regulatory, quality, and data privacy requirements.
• Design and build minimally viable AI/ML prototypes and proof of concepts (POCs), including LLM-based agents and automation solutions, using tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms.
• Develop or utilize connectors and integrations between AI tools and PV systems (e.g., APIs, data pipelines, middleware).
• Rapidly translate ideas to address 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 for PV use cases and establish prompt and accuracy governance.
• Continuously 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.

Qualifications

Experience in PV systems and processes combined with applied AI/ML capabilities. Hands-on expertise in rapidly prototyping AI-enabled solutions using tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms. Ability to build minimally viable proof-of-concepts (POCs), including establishing system integrations (APIs, connectors, data flows), to demonstrate real-world applicability within PV workflows.