Director of Pharmacovigilance & Safety

Hippocratic AI is the leading generative AI company in healthcare. We have the only system that can have safe, autonomous, clinical conversations with patients, with over 99.9% accuracy. We are contracted with 5 of the top 20 pharma globally and are in hyper growth for our Life Sciences vertical.

Reinvent healthcare with AI that puts safety first. We're building the world's first healthcare‑only, safety‑focused LLM — designed to transform patient outcomes at a global scale.

Work with the people shaping the future. Co‑founded by CEO Munjal Shah and a team of physicians, hospital leaders, and AI pioneers from Johns Hopkins, Stanford, Google, Meta, Microsoft, and NVIDIA.

Backed by the world's leading investors. We raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, with total funding of $404M from Capital

G, General Catalyst, a16z, Kleiner Perkins, and others.

Location: Palo Alto office, five days a week.

The Head of Pharmacovigilance and Safety will build and lead the safety infrastructure enabling Hippocratic AI to operate compliantly across every patient interaction. You will own PV systems, adverse event processes, safety governance, and signal detection — giving pharma and medtech partners confidence that safety is never compromised.

This is a creatively challenging role: you are not maintaining a mature PV operation but designing how pharmacovigilance works when the front line is an AI agent. You will invent the frameworks and build the systems that become the industry blueprint for AI-enabled pharmacovigilance. You will report to the VP of Medical Affairs and work closely with the President of Life Sciences, CCO, Legal, Product, and Engineering.

• Design and build the company's PV infrastructure — processes, systems, and governance for monitoring AI-driven patient interactions for AEs, product complaints, and safety signals.
• Define AE detection, capture, classification, documentation, and reporting within AI agent conversations; develop escalation rules for real-time AE identification at scale.
• Operationalize end-to-end AE processing: intake, triage, MedDRA coding, causality evaluation, narrative authoring, regulatory submission, and follow-up.
• Build and maintain a safety case database and QMS meeting FDA, EMA, and global standards; establish aggregate reporting (PSURs, PADERs, DSURs). Define SLAs, quality metrics, and compliance KPIs.

• Design signal detection capabilities leveraging AI-driven patient engagement data to identify safety patterns across millions of structured conversations.
• Partner with Engineering and Data Science to build automated signal detection tools, trend dashboards, and anomaly detection models.
• Pioneer AI-enabled PV approaches: NLP for AE detection, predictive safety modeling, and real-world safety evidence generation.

• Serve as the company's primary safety and PV authority in enterprise deals, vendor qualification, audits, and partnership governance.
• Develop customer-facing PV documentation: safety management plans, PVAs, SDEAs, reconciliation processes, and audit-readiness materials.
• Participate in customer safety audits and inspections; navigate therapeutic-area-specific safety requirements.

• Ensure compliance with FDA 21 CFR Parts 312/314, EMA GVP Modules, ICH E2B(R3)/E2D, MedDRA, and applicable global regulations. Maintain inspection readiness at all times.
• Develop and maintain PV SOPs, work instructions, and training materials; monitor evolving PV regulations and advise leadership on implications.
• Partner with Engineering and Product to embed PV logic into the AI platform — AE detection, safety escalation, and case capture built into conversation architecture.
• Define safety requirements for new platform features; build safety monitoring dashboards and real‑time alerting systems.

• 7–15 years in pharmacovigilance, drug safety, or clinical safety within pharma, biotech, CRO, or life sciences, with progressive responsibility for PV system design…