Director, Safety and PV Systems – Innovation, AI

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

📋 Description

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

• Spearhead cross-functional collaboration with internal teams and external vendors/system integrators; set up governance, SLAs/KPIs, and validated deployments.

• Lead innovation councils with clients and partners; transform problem statements into pilots/Proofs of Concept (PoCs) and expand successful patterns into offerings.

• Act as the solution lead for Requests for Information (RFIs) and Requests for Proposals (RFPs), covering reference architectures, delivery models, scope/estimation, commercial structures, and oral/bid defenses.

• Share insights through publications, present at conferences/webinars, brief executives, and facilitate demos, workshops, and innovation sessions.

• Oversee a small senior team, including mentoring, portfolio planning, resourcing, budget management, and benefits realization.

• Integrate risk-based quality, privacy, and security by design in collaboration with QA/Compliance and Data Privacy.

• Design and develop minimally viable AI/ML prototypes and proof of concepts, including LLM-based agents and automation solutions.

• Create or utilize connectors and integrations between AI tools and pharmacovigilance systems.

• Convert pharmacovigilance operational challenges into functional demos to assess feasibility and business value.

• Collaborate with engineering teams to transition Proofs of Concept into scalable solutions.

• Design and refine prompt frameworks, establishing prompt and accuracy governance.

• Enhance AI outputs through testing, feedback loops, and performance monitoring.

• Assist in AI model validation, monitoring, explainability, and risk management.

• Guide and mentor AI/PV specialists.

⛳️ Requirements

• Proven experience and extensive expertise in pharmacovigilance systems and technology solutions.

• Understanding of case intake/processing, signal management, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics.

• Familiarity with governance, SLAs/KPIs, validated deployments, CSV, 21 CFR Part 11, EU Annex 11, and GAMP 5.

• Experience in leading cross-functional teams and collaborating with external vendors/system integrators.

• Background in RFIs/RFPs, reference architectures, delivery models, estimation, commercial constructs, and bid defenses.

• Knowledge of AI/NLP/RPA, data platforms, cloud computing, real-world data, and advanced analytics.

• Proficient in designing and building AI/ML prototypes, LLM-based agents, and automation solutions.

• Experience with OpenAI, Azure OpenAI, Microsoft Copilot, and similar platforms.

• Capable of developing connectors and integrations using APIs, data pipelines, or middleware.

• Skilled in prompt engineering, prompt governance, AI output testing, model validation, monitoring, explainability, and risk management.

• Demonstrated leadership and mentoring capabilities.

• Equivalent experience, skills, or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Access to extensive resources including emerging technologies, data, and knowledge sharing.

• Diverse career paths and employment opportunities available.