Senior Director, Medical Safety Assessment Program Lead, Neuroscience
Core
Lead safety activities and benefit-risk strategies for assigned neuroscience compounds, chairing the product Safety Management Team and coordinating Medical Safety Assessment Physicians.
Role type
Senior Director, Medical Safety Assessment Program Lead
Builds
Safety aggregate reports, regulatory filings, risk management plans, and safety labeling for neuroscience medicines.
Domain
Pharmaceutical / Neuroscience / Pharmacovigilance
Required skills
Pharmacovigilance, benefit-risk assessment, signal evaluation, regulatory strategy, risk management planning, safety labeling, clinical development support, postmarketing safety oversight, process improvement, cross-functional leadership
Preferred skills
Neurology or psychiatry specialization, clinical research experience, observational research experience, clinical practice experience
Technologies
DSUR, PBRER, CTA, MAA, CSR, IB, ICF, SAP, RMP
Responsibilities
Lead safety labeling activities and act as Safety Subject Matter Expert for regulatory product labeling; Coordinate Medical Safety Assessment Physicians for signal evaluation and management; Represent the team at Health Authority and Data Monitoring Committee meetings; Lead process improvement projects for pharmacovigilance procedures; Provide safety input to clinical development plans, protocols, and statistical analysis plans; Oversee execution of risk management strategies and risk management plans.
Seniority
Senior Director, strategic leadership & mentorship