Senior Medical Director, Immunology, Global Patient Safety
Core
Lead patient safety strategy for immunology products throughout the product lifecycle, including surveillance, signal detection, and risk management.
Role type
Senior Medical Director, Patient Safety
Builds
Safety components of regulatory submissions (NDA/sNDA), Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs/DSURs)
Domain
Pharmaceutical/Biotech, Immunology, Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Patient safety strategy, regulatory interpretation (pharmacovigilance), aggregate safety data analysis, risk management planning, technical document authorship, cross-functional leadership
Preferred skills
Immunology/Internal medicine clinical experience, marketing authorization application submissions, clinical development experience
Technologies
None stated
Responsibilities
Analyze and interpret aggregate safety data for cross-functional teams and leadership; Lead strategy for key pharmacovigilance documents and regulatory submissions; Apply regulatory guidance for safety surveillance; Oversee periodic safety reports (DSURs, PSURs, PADERs); Implement risk management strategies for assigned products
Seniority
Senior, hands-on IC with leadership