Director of Pharmacovigilance & Safety

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.

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Requirements

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 teams to ensure that pharmacovigilance is integrated into the AI platform.