AI Post-Market Surveillance Signal Analyst

Orbio AI

Remote · $160k – $200k / year · Full-time · Posted 3 months ago

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About the role

We serve over 200 enterprise clients in the pharmaceutical and biotech sector, and our post-market safety platform is now the primary signal source for three top-20 pharma companies. Reliability and auditability are non-negotiable when a false negative could mean a missed adverse event. You will own the statistical models that scan spontaneous reporting databases, claims data, and social listening feeds for early safety signals, then translate raw scores into evidence packages that regulatory affairs teams can defend in front of health authorities. This is a senior individual contributor role reporting to our Head of Data Science, with direct exposure to pharmacovigilance leadership at client organizations and a seat in quarterly regulatory review calls.

Fully remote.

Responsibilities

Own statistical disproportionality models used for signal detection across multiple data sources
Partner with pharmacovigilance scientists to translate model output into audit-ready evidence packages
Maintain data pipelines ingesting spontaneous reports, claims data, and literature feeds
Present model methodology and validation results during client regulatory review calls
Continuously calibrate detection thresholds against known historical safety signals

Requirements

6+ years working with statistical or ML models in a regulated healthcare context
Strong command of Python, SQL, and applied statistics (disproportionality analysis a plus)
Experience explaining model behavior to non-technical regulatory stakeholders
Comfortable working with sensitive, compliance-heavy datasets