Global PV Operations Leader

Orchard Therapeutics - U.S.; Greater London; Hybrid; GBP 110,000 - 150,000; Full time

Job summary

Orchard Therapeutics seeks a Senior Manager, PV Operations to lead global pharmacovigilance operations. You will drive case intake, processing, and submissions, ensuring regulatory compliance across clinical and post-marketing portfolios. You will manage PV vendors and ensure inspection readiness.

The role collaborates with cross-functional teams to optimize data quality for signal detection, aggregate reporting, and RMPs, while maintaining robust, scalable PV systems and processes.

Qualifications

• Bachelor's degree or equivalent in life science, pharmacy, nursing, or related health field.
• Advanced degree in a relevant scientific or health-related field is desirable.
• Experience with PV systems and safety databases (Veeva preferred).
• Knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA).

Responsibilities

• Lead and improve global safety operations processes for case intake, processing, and submissions.
• Oversee timely case processing and regulatory reporting of ICSRs and act as database administrator for the Orchard safety database (Veeva Safety).
• Provide strategic leadership for selection, configuration, validation, and lifecycle management of safety systems and tools.
• Develop SOPs, work instructions, and training for safety operations.
• Support inspection readiness and audits by Health Authorities and partners.

Skills

PV Operations

Vendor management

Global ICSR management

Regulatory reporting

PM/leadership

Education

Bachelor's degree in life sciences or related field

Advanced degree in relevant field (Desirable)

Tools

Veeva Safety

MS Office

Job description

Orchard Therapeutics seeks a Senior Manager, PV Operations to lead global pharmacovigilance operations. You will drive case intake, processing, and submissions, ensuring regulatory compliance across clinical and post-marketing portfolios. You will manage PV vendors and ensure inspection readiness.

The role collaborates with cross-functional teams to optimize data quality for signal detection, aggregate reporting, and RMPs, while maintaining robust, scalable PV systems and processes.