Director, Safety Scientist
Core
Leading global patient safety risk management, regulatory strategy, and team mentorship for pharmaceutical products.
Role type
Director, Safety Scientist
Builds
Safety strategies, regulatory filings, and risk management plans for designated therapeutic areas.
Domain
Pharmaceutical/Biotech - Drug Safety and Regulatory Compliance
Deliverable
client delivery
Required skills
Strategic leadership, risk management evaluation, regulatory analysis, vendor management, project distribution, safety data review, signal management, document authoring (PSUR, PBER, RMP, CSRs), therapeutic area expertise
Preferred skills
Clinical and safety database expertise, MedDRA coding, independent judgment, time management, project management, Microsoft Office mastery
Technologies
MedDRA, Microsoft Word, PowerPoint, Excel
Responsibilities
Lead risk management evaluation and resolution for assigned products; organize and train junior safety scientists; co-lead new drug application activities; represent global patient safety at regulatory inspections; lead analysis to identify and address changes in global regulations; manage vendor management and training budgets; participate in ongoing safety data review and analysis; lead Signal Review Meeting activities; author safety documents including PSUR, PBER, RMP, and CSRs; manage portfolio of products/projects related to risk management.
Seniority
Director, strategic leadership & mentorship
