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Senior Functional Safety Engineer (ISO 21448)

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StageNot listed in company directoryStandardsISO 21448 · UL 4600 · ISO 8800IndustryAI & software platformsSenioritySeniorRegionGermanySource year2026Role familyProduct safetyEmployerNot in the directory
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Role summary

We are looking for an experienced pharmacovigilance professional to serve as our Senior Safety Domain Expert for the organization Falcon. In this role, you will bridge hands-on case processing execution with high-level strategic vision for the future of PV Operations, directly shaping next-generation AI and automation tools. You will spend your days collaborating with our internal technical teams and external early adopters, acting as the definitive "Voice of the Customer" to ensure our platform delivers flawless safety automation.

Responsibilities

  • End-to-End Workflow Guidance: Advise product and engineering teams on the detailed steps of safety case intake, triage, validation, and advanced data reconciliation workflows
  • AI Calibration & Verification: Actively review, evaluate, and verify AI-driven platform outputs across case intake and processing steps to ensure maximum precision, accuracy, and safety compliance
  • Strategic PV Ops Vision: Translate macro industry trends and operational shifts in PV into actionable platform capabilities and long-term automation strategies
  • Early Adopter Engagement: Interact directly with PV leads and processing specialists at early adopter organizations, translating their feedback into actionable platform enhancements
  • Stress-Test Scenario Building: Map out highly complex, multi-variable safety case scenarios to rigorously evaluate and calibrate the platform's reasoning boundaries

Requirements

  • 5+ years of active experience in Pharmacovigilance / Drug Safety Operations
  • Deep tactical understanding of day-to-day case processing workflows, intake, validation criteria, database reconciliation, and global expedited reporting timelines
  • Strategic PV Operations expertise with a clear vision of how PV operating models are evolving toward automation and digital transformation
  • Demonstrated AI experience, including active involvement with AI-driven software, automated workflow tools, agentic AI, or machine learning applications in pharmacovigilance or life sciences
  • Strong ability to bridge PV operational knowledge with technical product teams and present confidently to executive customers

Nice to have

  • Prior experience contributing to the design, implementation, or user-acceptance testing (UAT) of automated pharmacovigilance intake solutions
  • Within 3 days, you will receive a link to a personality assessment administered by a third party.
  • Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
  • If moving to the interview stage, the process is as follows
  • A conversation with the hiring manager
  • A practical case exercise
  • A final conversation with our group's Senior Leader.
  • Once all interviews are complete, the manager will be in touch with a final decision.

Standards

  • ISO 21448 SOTIF - Safety of the Intended Functionality
  • UL 4600 Evaluation of Autonomous Products
  • ISO 8800 Road Vehicles - Safety and Artificial Intelligence

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