Senior Medical Director, Neuroscience, Global Patient Safety
Core
Lead global patient safety and pharmacovigilance activities for neuroscience products, ensuring safety through surveillance, signal detection, and regulatory compliance.
Role type
Senior Medical Director (Neuroscience, Patient Safety)
Builds
Safety strategies for regulatory submissions (INDs, NDAs, MAAs) and periodic reports (PSURs, PADERs) for neuroscience products.
Domain
Pharmaceutical/Biotech, Neuroscience, Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance experience, clinical data analysis, epidemiological information analysis, regulatory guidance application, technical document authorship, risk management strategy implementation
Preferred skills
Master of Public Health (MPH), patient management experience
Technologies
None stated
Responsibilities
Conduct safety surveillance for pharmaceutical/biological/drug-device combined neuroscience products; Author key pharmacovigilance documents including medical safety assessments and risk management plans; Analyze and interpret aggregate safety data; Lead safety strategy for regulatory submissions and periodic reports; Oversee safety surveillance and pharmacovigilance activities in clinical trials and post-marketing; Implement risk management strategy for assigned products.
Seniority
Senior, hands-on IC