Director of Pharmacovigilance & Safety

About the Company

Hippocratic AI is the leading generative AI company in healthcare, building a breakthrough platform designed to transform patient outcomes through safe, autonomous, clinical conversations. Backed by leading Life Science and AI investors, the company is rapidly expanding its Life Sciences vertical to support patients and healthcare stakeholders across the entire value chain.

Responsibilities

• Design and build the company's pharmacovigilance infrastructure, including processes, systems, and governance frameworks for AI-driven patient interactions.
• Define logic and escalation rules for real-time adverse event (AE) identification within AI agent conversations.
• Develop end-to-end AE processing workflows including intake, triage, MedDRA coding, and regulatory submission.
• Establish aggregate safety reporting capabilities such as PSURs, PADERs, and DSURs.
• Design and implement AI-driven safety signal detection capabilities to analyze large-scale conversation data.
• Serve as the primary safety authority for enterprise customers during deal cycles, vendor qualifications, and audits.
• Partner with Engineering and Product teams to embed pharmacovigilance logic directly into the AI platform architecture.
• Ensure all operations comply with global regulations including FDA 21 CFR, EMA GVP, and ICH guidelines.

Requirements

• 7-15 years of experience in pharmacovigilance, drug safety, or clinical safety within pharma, biotech, or CRO environments.
• Deep expertise in global PV regulations (FDA, EMA GVP, ICH) and MedDRA coding.
• Proven track record of building or significantly expanding PV operations and case management infrastructure.
• Experience engaging with senior-level pharma PV, safety, and regulatory stakeholders.
• Ability to translate complex PV requirements into technical specifications for engineering and data science teams.
• Strong understanding of the end-to-end AE lifecycle and signal detection.

Preferred Qualifications

• Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, PhD, MD, MSN, MPH).
• Experience with AI, digital health, or automated patient engagement platforms.
• Familiarity with safety database systems like Argus, ArisG, or Veeva Vault Safety.
• Experience with medical device vigilance and post-market surveillance.
• Qualified Person for Pharmacovigilance (QPPV) designation.
• Experience in high-growth startup environments.