Head of Pharmacovigilance & Safety

📋 Description

• • Hippocratic AI is at the forefront of healthcare innovation, pioneering generative AI solutions designed for safe and autonomous clinical conversations with patients. Our proprietary LLMs, part of the Polaris constellation, achieve over 99.9% accuracy, positioning us as a leader in the rapidly expanding pharma and medtech industries. We are developing a new generation of agentic AI agents to support patients and healthcare stakeholders across the entire life sciences value chain, including patient services, clinical trials, access, adherence, and healthcare professional (HCP) workflows. With existing contracts with five of the top twenty global pharmaceutical companies, we are experiencing hyper-growth within our Life Sciences vertical.
• • This role offers a unique opportunity to reinvent healthcare by building the world's first safety-focused, healthcare-only LLM platform. You will be instrumental in transforming patient outcomes on a global scale, participating in true category creation. Join a distinguished team co-founded by CEO Munjal Shah and comprised of leading physicians, hospital executives, AI pioneers, and researchers from prestigious institutions such as El Camino Health, Johns Hopkins, Washington University in St. Louis, Stanford, Google, Meta, Microsoft, and NVIDIA.
• • Hippocratic AI is backed by premier Life Science and AI investors, having recently secured a $126M Series C funding round at a $3.5B valuation, led by Avenir Growth. Our total funding now stands at $404M, with significant contributions from investors including CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children’s, WellSpan Health, John Doerr, and Rick Klausner.
• • As the Head of Pharmacovigilance and Safety, you will architect and lead the safety infrastructure essential for Hippocratic AI's credible and compliant operation across all patient interactions. This leadership position encompasses ownership of pharmacovigilance systems, adverse event (AE) processes, safety governance, and signal detection capabilities. Your mandate is to ensure our pharma and medtech partners have unwavering confidence in the safety protocols underpinning our AI agents' patient communications.
• • This is an exceptionally challenging and creative safety role within the current healthcare landscape. Unlike traditional roles focused on maintaining established PV operations, you will be designing pharmacovigilance from its foundations for an AI-first environment. Every aspect of AE capture, triage, documentation, and reporting must be re-envisioned for a world where AI agents manage millions of patient interactions simultaneously across diverse therapeutic areas. You will define the industry's blueprint for AI-enabled pharmacovigilance by inventing novel frameworks, setting new standards, and building robust systems.
• • You will collaborate with leading experts in healthcare and AI, contributing to a platform that is not only powerful and transformative but also fundamentally trusted. This role reports to the VP of Medical Affairs and works closely with the President of Life Sciences, Chief Commercial Officer, Sales, Legal, Customer Success, Product, and Engineering leadership.
• • Key responsibilities include designing and building the company's pharmacovigilance infrastructure from the ground up, establishing processes, systems, and governance for monitoring AI-driven patient interactions for AEs, product complaints, and safety signals. You will define how AEs are detected, captured, classified, documented, and reported within AI conversations, developing the logic, language models, and escalation rules for real-time AE identification at scale.
• • Operationalizing end-to-end AE processing workflows, including intake, triage, case assessment, MedDRA coding, causality evaluation, narrative authoring, regulatory submission, and follow-up, adapted for AI-generated interactions, is crucial. You will build and maintain a safety case database and quality management system compliant with FDA, EMA, and other global regulatory authorities, and establish aggregate safety reporting capabilities (PSURs, PADERs, DSURs).
• • Defining SLAs, quality metrics, and performance standards for the PV operation, including case processing timelines and compliance KPIs, will be essential. Developing and managing safety escalation pathways to ensure immediate routing of medically significant events to qualified medical reviewers is also a core function.
• • Furthermore, you will design and implement innovative safety signal detection capabilities leveraging AI's unique advantages in analyzing millions of structured conversations for emerging safety patterns. This includes developing frameworks for proactive safety monitoring that surpass regulatory minimums, using platform interaction data for earlier and more sensitive signal detection.
• • Partnering with Engineering and Data Science to build automated signal detection tools, trend analysis dashboards, and anomaly detection models will provide real-time safety profile visibility. You will explore and pioneer new AI-enabled PV approaches, potentially leading to publications and presentations that establish Hippocratic AI as a thought leader.
• • As the primary safety and PV authority in customer-facing contexts, you will engage directly with pharma and medtech partner PV, safety, quality, and regulatory teams. This involves demonstrating platform safety capabilities, AE handling processes, and compliance infrastructure, as well as developing customer-facing PV documentation like safety management plans and PVAs.
• • You will support Sales and Customer Success by providing the safety and PV credibility needed to differentiate Hippocratic AI and accelerate deal cycles, especially with large pharma organizations. Direct participation in customer safety audits, inspections, and governance reviews is expected, representing the company's PV posture with authority.
• • Ensuring compliance with global regulations (FDA, EMA GVP, ICH guidelines, MedDRA) is paramount. You will develop and maintain PV SOPs, monitor evolving regulations, and partner with Legal and Compliance to ensure data handling meets privacy requirements (HIPAA, GDPR).
• • Collaboration with Engineering and Product teams to embed PV logic directly into the AI platform is key, ensuring AE detection and safety escalation are integral to the conversation architecture. You will define safety requirements for new features and work with Engineering to build scalable safety monitoring tools.
• • Partnering with the Data Science team to train and validate AI models for AE detection accuracy, ensuring performance meets or exceeds human-operated PV systems, is critical. You will also contribute to the company's overall clinical governance framework alongside Medical Affairs.