Director, Safety and PV Systems – Innovation, AI

This is a fully remote position, open to applicants in United States.

📋 Description

• Responsible for the roadmap and execution of comprehensive SPVG technology solutions, encompassing case intake/processing, signal detection, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics—striking a balance between speed, compliance, and value.

• Directs cross-functional implementation with internal teams and external vendors/SIs; sets governance, SLAs/KPIs, and validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5).

• Leads innovation councils with customers and partners; transforms problem statements into pilots/PoCs with defined success criteria and scales validated patterns into offerings.

• Acts as the solution lead for RFIs/RFPs: developing reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses.

• Shares insights through published viewpoints, presentations at conferences/webinars, and executive briefings on the PV technology landscape (AI/NLP/RPA, data platforms, cloud, real-world data, advanced analytics).

• Conducts live demonstrations, workshops, and innovation sessions.

• Oversees a small, senior team: providing mentorship; managing portfolio planning, resource allocation, budgets, and benefits realization.

• Integrates risk-based quality, privacy, and security by design; collaborates closely with QA/Compliance and Data Privacy to ensure all solutions comply with regulatory, quality, and data privacy standards.

• Designs and develops minimally viable AI/ML prototypes and proof of concepts (POCs), including LLM-based agents and automation solutions, utilizing tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms.

• Creates or employs connectors and integrations between AI tools and PV systems (e.g., APIs, data pipelines, middleware).

• Quickly translates ideas to tackle PV Operational challenges into functional demos to validate feasibility and business value.

• Collaborates with engineering teams to transition POCs into scalable solutions.

• Designs and optimizes prompt frameworks for PV use cases and establishes governance for prompt and accuracy.

• Continuously enhances AI outputs through testing, feedback loops, and performance assessments.

• Supports AI model validation, monitoring, explainability, and risk management.

• Guides and mentors AI/PV specialists.

⛳️ Requirements

• Responsible for the roadmap and execution of comprehensive SPVG technology solutions, encompassing case intake/processing, signal detection, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics.

• Directs cross-functional implementation with internal teams and external vendors/SIs; sets governance, SLAs/KPIs, and validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5).

• Leads innovation councils with customers and partners; transforms problem statements into pilots/PoCs with defined success criteria and scales validated patterns into offerings.

• Acts as the solution lead for RFIs/RFPs: developing reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses.

• Shares insights through published viewpoints, presentations at conferences/webinars, and executive briefings on the PV technology landscape (AI/NLP/RPA, data platforms, cloud, real-world data, advanced analytics).

• Conducts live demonstrations, workshops, and innovation sessions.

• Oversees a small, senior team: providing mentorship; managing portfolio planning, resource allocation, budgets, and benefits realization.

• Integrates risk-based quality, privacy, and security by design; collaborates closely with QA/Compliance and Data Privacy to ensure all solutions comply with regulatory, quality, and data privacy standards.

• Designs and develops minimally viable AI/ML prototypes and proof of concepts (POCs), including LLM-based agents and automation solutions, utilizing tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms.

• Creates or employs connectors and integrations between AI tools and PV systems (e.g., APIs, data pipelines, middleware).

• Quickly translates ideas to tackle PV Operational challenges into functional demos to validate feasibility and business value.

• Collaborates with engineering teams to transition POCs into scalable solutions.

• Designs and optimizes prompt frameworks for PV use cases and establishes governance for prompt and accuracy.

• Continuously enhances AI outputs through testing, feedback loops, and performance assessments.

• Supports AI model validation, monitoring, explainability, and risk management.

• Guides and mentors AI/PV specialists.

🏝️ Benefits

• We are committed to the professional development of our team members, offering opportunities for career advancement and progression.

• Supportive and engaged management team.

• Access to technical and therapeutic area training.

• Peer recognition and a comprehensive rewards program.

• Dedication to fostering an inclusive culture—where you can genuinely be yourself.