🛠 Tech Stack

💼 About This Role

You'll lead safety surveillance for in vitro diagnostic and software-driven products across their lifecycle. Your core impact is ensuring compliance with global regulations (FDA, EU IVDR, Japan) and maintaining the highest patient safety standards. This role uniquely combines pharmacovigilance and device vigilance responsibilities.

🎯 What You'll Do

• Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs)
• Coordinating medical review and causality assessment of adverse events
• Evaluate reportability of events under FDA MDR and EU IVDR vigilance
• Assess safety events associated with software algorithm errors

📋 Requirements

• Bachelor's degree in life science field
• Minimum of 12 years direct experience in pharmacovigilance/device vigilance
• Strong knowledge of global safety regulations (FDA, EMA, ICH, EU IVDR, Japan)
• Experience with safety databases (e.g., Argus, ARISg, Veeva Safety)

✨ Nice to Have

• Advanced degree (PharmD, MD, MPH, MSc)
• RAC certification
• Prior audit/inspection experience

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 45 min
3. 3Panel interview· 60 min