Senior Director, Global Safety Physician
Core
Lead global clinical safety strategy, signal detection, and benefit-risk evaluation for investigational and marketed biopharmaceutical products.
Role type
Senior Director, Global Safety Physician (Medical Expert)
Builds
Regulatory filings (INDs, NDAs/BLAs), safety reports (DSURs, PBRERs, RMPs), and safety responses to health authority queries.
Domain
Biopharmaceuticals / Clinical Safety & Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP, ICH E2E, GVP modules, safety signal detection, benefit-risk assessment, regulatory interaction, strategic leadership
Preferred skills
Specialty training in relevant therapeutic areas, experience with matrixed global environments
Technologies
Argus, ArisGlobal, MedDRA
Responsibilities
Provide medical oversight for clinical safety signals; lead or participate in safety signal detection, evaluation, and validation; author or review safety content in critical regulatory documents; support regulatory filings and interactions; partner with cross-functional teams to align on safety strategy.
Seniority
Senior Director, executive-level leadership
