About the role
About Us Hippocratic AI is the leading generative AI company in healthcare. We have the only system that can have safe, autonomous, clinical conversations with patients. We have trained our own LLMs as part of our Polaris constellation, resulting in a system with over 99.9% accuracy. Hippocratic AI is rapidly expanding across the pharma and medtech industries. We are building a new class of agentic AI that supports patients and healthcare stakeholders across the entire life sciences value chain including patient services, clinical trials, access, adherence, and HCP-facing workflows. We are contracted with 5 of the top 20 pharma globally and are in a hyper growth phase for our Life Sciences vertical. Why Join Our Team Reinvent healthcare with AI that puts safety first. We’re building the world’s first healthcare‑only, safety‑focused LLM — a breakthrough platform designed to transform patient outcomes at a global scale. This is category creation. Work with the people shaping the future. Hippocratic AI was co‑founded by CEO Munjal Shah and a team of physicians, hospital leaders, AI pioneers, and researchers from institutions like El Camino Health, Johns Hopkins, Washington University in St. Louis, Stanford, Google, Meta, Microsoft, and NVIDIA. Backed by the world’s leading Life Science and AI investors. We recently raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, bringing total funding to $404M with participation from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children’s, WellSpan Health, John Doerr, Rick Klausner, and others. We are seeking a Head of Pharmacovigilance and Safety to build and lead the safety infrastructure that enables Hippocratic AI to operate credibly and compliantly across every patient interaction our platform touches. This leader will own the pharmacovigilance systems, adverse event processes, safety governance, and signal detection capabilities that give our pharma and medtech partners confidence that when our AI agents speak to patients, safety is never compromised. This is one of the most creatively challenging safety roles in healthcare today. You are not inheriting a mature PV operation and maintaining it — you are designing how pharmacovigilance works when the front line is an AI agent, not a human call center representative. Every assumption about how adverse events are captured, triaged, documented, and reported needs to be rethought for a world where AI agents conduct millions of patient interactions across dozens of therapeutic areas simultaneously. You will invent the frameworks, define the standards, and build the systems that become the industry blueprint for AI-enabled pharmacovigilance. Build alongside the best in healthcare and AI. Join experts who’ve spent their careers improving care, advancing science, and building world‑changing technologies — ensuring our platform is powerful, trusted, and truly transformative. Location Requirement We believe the best ideas happen together. To support fast collaboration and a strong team culture, this role is expected to be in our Palo Alto office five days a week, unless otherwise specified. About the Role The Head of Pharmacovigilance and Safety is responsible for building and managing the pharmacovigilance programs, safety systems, and adverse event processes that support Hippocratic AI's commercial growth and customer relationships across regulated healthcare and life sciences environments. You will serve as the company's lead on drug safety, adverse event management, safety signal detection, and pharmacovigilance compliance — with a particular focus on enabling enterprise sales and ensuring pharma and medtech partners have full confidence in the platform's safety infrastructure. You will work directly with pharma partner safety, PV, and quality teams during deal cycles, vendor qualification, and ongoing deployment governance. Internally, you will partner with Engineering, Product, Medical Affairs, Customer Success, and Compliance to ensure the platform's safety capabilities are robust, auditable, and continuously improving. You will report to the VP of Medical Affairs, and work closely with the President of Life Sciences, Chief Commercial Officer, Sales, Legal, Customer Success, Product, and Engineering leadership. What You'll Do Pharmacovigilance System Design and Operations Design and build the company's pharmacovigilance infrastructure from the ground up — creating the processes, systems, and governance frameworks for how AI-driven patient interactions are monitored for adverse events, product complaints, and safety signals. Define how adverse events are detected, captured, classified, documented, and reported within AI agent conversations — developing the logic, language models, and escalation rules that enable real-time AE identification at scale across therapeutic areas and product types. Develop and operationalize end-to-end AE processing workflows including intake, triage, case assessment, MedDRA coding, causality evaluation, narrative authoring, regulatory submission, and follow-up — adapted for the unique characteristics of AI-generated interactions. Build and maintain a safety case database and quality management system that meets regulatory standards and supports audit readiness across FDA, EMA, and other global regulatory authorities. Establish aggregate safety reporting capabilities including PSURs, PADERs, DSURs, and ad hoc safety analyses as required by pharma partners and regulatory obligations. Define SLAs, quality metrics, and performance standards for the PV operation — including case processing timelines, data quality benchmarks, and compliance KPIs. Develop and manage safety escalation pathways that ensure medically significant events are routed immediately to qualified medical reviewers, regardless of time or volume. Safety Signal Detection and Innovation Design and implement safety signal detection capabilities that leverage the unique advantages of AI-driven patient engagement — including the ability to analyze millions of structured conversations for emerging safety patterns that traditional PV methods would miss. Develop frameworks for proactive safety monitoring that go beyond regulatory minimums — using platform interaction data to identify potential signals earlier, with greater sensitivity, and across broader patient populations than conventional passive surveillance. Partner with Engineering and Data Science to build automated signal detection tools, trend analysis dashboards, and anomaly detection models that provide real-time visibility into the safety profile of every product the platform supports. Explore and pioneer new approaches to AI-enabled pharmacovigilance — including natural language processing for AE detection, predictive safety modeling, patient-reported outcome integration, and real-world safety evidence generation. Publish and present on innovations in AI-enabled PV, establishing Hippocratic AI as a thought leader in the future of drug and device safety. Customer-Facing Safety and PV Partnership Serve as the company's primary safety and PV authority in all customer-facing contexts — including enterprise deal cycles, vendor qualification reviews, safety audits, and ongoing partnership governance. Engage directly with pharma and medtech partner PV, safety, quality, and regulatory teams to demonstrate the platform's safety capabilities, AE handling processes, and compliance infrastructure. Develop customer-facing PV documentation including safety management plans, PV agreements (PVAs), safety data exchange agreements (SDEAs), reconciliation processes, and audit-readiness materials that meet the standards pharma partners require from qualified safety vendors. Support Sales and Customer Success by providing safety and PV credibility that differentiates Hippocratic AI from competitors and accelerates deal cycles — particularly with pharma organizations where PV qualification is a gating factor in vendor selection. Participate directly in customer safety audits, inspections, and governance reviews — representing the company's PV posture with the depth and confidence that pharma safety leaders expect. Navigate customer-specific safety requirements across therapeutic areas — understanding that PV expectations for an oncology supportive care program differ meaningfully from those for a diabetes device onboarding program or a post-surgical follow-up workflow. Regulatory Compliance and Global Safety Standards Ensure all pharmacovigilance operations comply with applicable global regulations including FDA 21 CFR Parts 312/314, EMA GVP Modules, ICH E2B(R3), ICH E2D, MedDRA standards, and applicable local regulations across deployment geographies. Develop and maintain pharmacovigilance SOPs, work instructions, and training materials that reflect current regulatory requirements and industry best practices. Monitor and interpret evolving PV regulations and guidance — including FDA's approach to AI in safety monitoring, EMA expectations for digital health pharmacovigilance, and emerging global standards for AI-enabled safety systems — and advise leadership on their implications. Partner with Legal and Compliance to ensure safety data handling meets HIPAA, GDPR, and industry-specific privacy requirements, particularly around patient health information captured during AI interactions. Prepare and maintain regulatory inspection readiness — ensuring the PV operation can withstand FDA, EMA, or partner-initiated audits at any time. Platform Integration and Engineering Partnership Partner with Engineering and Product to embed pharmacovigilance logic directly into the AI platform — ensuring that AE detection, safety escalation, and case capture are built into the conversation architecture rather than layered on as post-processing. Define safety requirements and acceptance criteria for new platform features, conversation flows, and therapeutic area deployments — ensuring every patient-facing capability is evaluated through a PV lens before launch. Work with Engineering to build safety monitoring dashboards, real-time alerting systems, and automated case processing tools that enable the PV operation to scale alongside platform growth. Collaborate with the Data Science team on training and validating AI models for AE detection accuracy, ensuring false negative rates for safety events meet or exceed the performance of human-operated PV systems. Contribute to the company's overall clinical governance framework alongside Medical Affairs — ensuring safety is integrated into the broader medical quality and oversight structure. What You Bring Must Have: 7-15 years of experience in pharmacovigilance, drug safety, or clinical safety within pharma, biotech, CRO, or life sciences services organizations — with progressive responsibility for PV system design, case processing operations, and regulatory compliance. Deep expertise in global pharmacovigilance regulations including FDA regulations, EMA GVP, ICH guidelines, MedDRA coding, and safety reporting requirements across major markets. Direct experience building or significantly expanding PV operations — not just maintaining inherited systems but designing processes, standing up case management infrastructure, and establishing quality standards. Demonstrated ability to engage credibly with pharma PV, safety, quality, and regulatory stakeholders at senior levels — including experience leading or participating in safety audits, PVA negotiations, and vendor qualification processes. Strong understanding of the end-to-end AE lifecycle from detection through regulatory submission, including ICSR processing, signal detection, aggregate reporting, and risk management. Ability to translate PV requirements into technical specifications and product requirements — working effectively with engineering and data science teams to embed safety capabilities into technology platforms. Comfort working in high-growth environments with limited structure and high expectations for ownership, innovation, and cross-functional collaboration. Exceptional written and verbal communication skills with the ability to make complex safety and regulatory concepts accessible to both customers and internal non-PV teams. Nice to Have: Experience with AI, digital health, or technology platforms in a pharmacovigilance or safety capacity — particularly in defining how AE detection and safety monitoring operate in digital or automated patient engagement environments. Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, PhD, MD, MSN, MPH) strongly preferred. Familiarity with safety database systems (e.g., Argus, ArisG, Veeva Vault Safety) and experience with system selection, configuration, or migration. Experience with medical device vigilance, complaint handling, and post-market surveillance in addition to drug safety. Qualified Person for Pharmacovigilance (QPPV) designation or equivalent experience. Startup or early-stage company experience. Certification in pharmacovigilance or drug safety is a plus. What We're Looking For: A pharmacovigilance leader who sees this moment for what it is — the chance to reinvent how drug and device safety operates in an era of AI-driven patient engagement, and to be the person who writes the playbook the industry follows. A systems builder who can design PV infrastructure from first principles, not just replicate what exists elsewhere, because what exists elsewhere wasn't built for a world where AI agents conduct patient interactions at scale. A customer-facing safety authority who gives pharma PV and quality leaders the confidence to say yes — because you speak their language, you've sat in their audits, and you know what their inspectors will ask. A creative thinker who looks at the data flowing through millions of AI-patient conversations and sees not just a compliance obligation but an unprecedented opportunity to detect safety signals faster, with greater precision, and at a scale that traditional PV has never achieved. An engineering-minded safety leader who can work with data scientists and developers to build AE detection and signal monitoring capabilities that push the entire field forward. A builder who wants to define what pharmacovigilance looks like when AI is the front line — and who understands that getting safety right isn't just a regulatory requirement, it's the foundation everything else is built on. Please be aware of recruitment scams impersonating Hippocratic AI. All recruiting communication will come from @ hippocraticai.com email addresses. We will never request payment or sensitive personal information during the hiring process.