Director of Pharmacovigilance & Safety

Hippocratic AI•Palo Alto, CA

1d•Onsite

About The Position

Hippocratic AI is 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.

Requirements

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 Haves

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.

Responsibilities

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.
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.
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.
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.
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.