Director, Medical Safety Assessment Physician
Core
Lead global medical safety activities, benefit-risk strategies, and regulatory safety submissions for assigned pharmaceutical compounds.
Role type
Director, Medical Safety Assessment Physician
Builds
Safety aggregate reports, regulatory filings, risk management plans, and clinical study documents for innovative medicines.
Domain
Pharmaceutical industry / Pharmacovigilance and Clinical Safety
Required skills
Benefit-risk assessment, signal detection and evaluation, regulatory safety reporting, risk management strategy development, clinical trial safety oversight, postmarketing safety management, cross-functional team leadership, regulatory filing preparation
Preferred skills
Experience with EU Qualified Person for Pharmacovigilance interactions, publication safety review, Health Authority meeting representation
Technologies
DSUR, PBRER, CSR, IB, ICF, CTA, MAA, RMP
Responsibilities
Chair product Safety Management Teams, lead safety labeling activities, support EU Qualified Person for Pharmacovigilance, provide safety input to R&D publications, represent the company at Health Authority and Data Monitoring Committee meetings, oversee periodic safety submissions and risk management plans.
Seniority
Director, strategic leadership and team management