Senior Global PV Operations Leader

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

Job summary

Orchard Therapeutics in London offers a hybrid Senior Manager, PV Operations role leading the global pharmacovigilance function. You will oversee case intake, ICSR processing, and regulatory reporting across clinical and post-marketing portfolios.

You will drive vendor management and SOP development, ensuring inspection readiness and robust PV systems in partnership with QA and cross-functional teams.

Qualifications

• Bachelor's degree in life sciences or related field.
• Extensive PV operations experience with global ICSR management.
• Strong knowledge of global PV regulations (GVP, ICH, EMA, MHRA).

Responsibilities

• Lead global PV operations and case processing.
• Oversee regulatory reporting of ICSRs and data quality.
• Manage PV vendors/CROs and associated audits.
• Develop, implement and maintain SOPs and training.
• Ensure inspection readiness and compliant PV systems.
• Collaborate with QA and cross-functional teams on data for signals and risk management.
• Oversee safety data exchange agreements and literature surveillance.

Skills

PV Operations

ICSR Management

Regulatory Reporting

Vendor Management

SOP Development

Inspection Readiness

Education

Bachelor's degree in life sciences

Tools

Veeva Safety

Job description

Orchard Therapeutics in London offers a hybrid Senior Manager, PV Operations role leading the global pharmacovigilance function. You will oversee case intake, ICSR processing, and regulatory reporting across clinical and post-marketing portfolios.

You will drive vendor management and SOP development, ensuring inspection readiness and robust PV systems in partnership with QA and cross-functional teams.