Senior Manager, PV Operations
Orchard Therapeutics
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Role summary
Orchard Therapeutics seeks a Senior Manager of Pharmacovigilance Operations to lead global safety case management, regulatory reporting, and compliance across clinical and post-marketing programs. The role reports to the VP Pharmacovigilance and serves as the operational interface between vendors, study teams, and internal stakeholders in a London-based hybrid position.
What they're looking for
- Bachelor's degree in life sciences, pharmacy, nursing, or related health field
- Extensive pharmacovigilance operations experience with global ICSR management leadership
- In-depth knowledge of global PV regulations including GVP, ICH, FDA, MHRA, EMA
- Experience with safety databases, preferably Veeva Safety, including configuration and validation
- Demonstrated ability to lead and manage PV vendors and CROs
- Experience with clinical studies, postmarketing safety, risk management plans, and aggregate reporting
- Pharmacovigilance or drug safety certification highly desirable
What you'll be doing
- Lead and improve global safety operations processes including case intake and regulatory submissions
- Oversee timely, compliant case processing and ICSR reporting across all sources
- Manage database administration for Veeva Safety and internal safety case management systems
- Direct selection, configuration, validation, and lifecycle management of safety systems and tools
- Design, implement, and maintain SOPs, work instructions, and training for safety operations
Privacy & handoff
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