Global PV Operations Lead Regulatory & Inspection Readiness

Orchard Therapeutics - U.S.; Greater London; Hybrid; GBP 100,000 - 180,000; Full time

Job summary

Orchard Therapeutics is seeking a Senior Manager, PV Operations to lead worldwide pharmacovigilance operations, ensuring timely case processing, regulatory reporting, and inspection readiness while partnering with PV vendors and cross-functional study teams.

The role requires deep PV regulatory knowledge, experience with PV systems and vendor oversight, and the ability to translate strategy into actionable plans that drive compliant, scalable PV operations.

Qualifications

• Extensive leadership in global ICSR management and regulatory reporting.
• Knowledge of GVP, ICH, FDA, MHRA, EMA regulations and practical implementation.
• Experience with PV vendors/CROs and PV systems configuration, validation, and maintenance.

Responsibilities

• Lead and improve global safety operations processes, including case intake, processing, and submissions, with oversight of PV vendors.
• Oversee timely and compliant case processing and regulatory reporting of ICSR from all sources; act as database admin for Orchard safety database (Veeva Safety).
• Ensure robust oversight of internal and external safety case management with performance monitoring and quality metrics.
• Provide strategic leadership for safety systems lifecycle management in partnership with IT and Vendor Safety Systems teams.
• Lead design, implementation, and maintenance of SOPs, work instructions, and training for safety operations.
• Act as SME supporting inspection readiness and audits related to PV operations, coordinating responses and remediation.
• Liaise with QA to ensure audit programmes run smoothly for PV components and partners.

Skills

PV Operations

Icsr Management

Vendor Management

Regulatory Reporting

SOP Development

Inspection Readiness

Education

Bachelor's in Life Sciences

PV Certification

Tools

Veeva Safety

Safety Databases

Job description

Orchard Therapeutics is seeking a Senior Manager, PV Operations to lead worldwide pharmacovigilance operations, ensuring timely case processing, regulatory reporting, and inspection readiness while partnering with PV vendors and cross-functional study teams.

The role requires deep PV regulatory knowledge, experience with PV systems and vendor oversight, and the ability to translate strategy into actionable plans that drive compliant, scalable PV operations.