Orchard Therapeutics

Operations

• Lead and continuously improve global safety operations processes, including case intake, processing, and submissions
• Oversee timely and compliant processing and regulatory reporting of Individual Case Safety Reports (ICSRs)
• Act as database business administrator for Orchard's Veeva Safety database
• Ensure operational oversight of internal and external safety case management, performance monitoring, and quality metrics
• Provide strategic leadership for selection, configuration, validation, and lifecycle management of safety systems and tools
• Lead the design, implementation, and maintenance of SOPs, work instructions, and training for safety operations
• Support inspection readiness, internal audits, Health Authority inspections, and partner audits, including response and remediation plans
• Liaise with Quality Assurance to coordinate audits of pharmacovigilance systems and partners
• Collaborate with safety physicians, safety scientists, and cross-functional teams on signal detection, aggregate safety reporting, benefit–risk assessments, and Risk Management Plans
• Provide senior operational input into Safety Management Teams and cross-functional project teams
• Manage operational feasibility, timelines, and compliance risks
• Lead operational aspects of safety data exchange agreements with partners and licensees
• Oversee literature surveillance workflows
• Report to the VP Pharmacovigilance

Senior Manager, PV Operations