Senior Manager, PV Operations

Orchard Therapeutics

. Lead and continuously improve global safety operations processes, including case intake, processing, and submissions .

Posted 9/22/2026full-timeLondon • United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in pharmacovigilance operations, including leadership in global ICSR management, regulatory reporting, and safety database administration. Proficient in implementing global PV regulations and driving continuous improvement in safety operations.

Highest-signal resume keywords

Pharmacovigilance OperationsIndividual Case Safety Reports (ICSRs)Veeva Safety DatabaseGlobal PV RegulationsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacovigilance OperationsIndividual Case Safety Reports (ICSRs)Safety Database AdministrationRegulatory ReportingSafety Data Exchange Agreements (SDEAs)Risk Management PlansAggregate Report PreparationProcess OptimizationClinical StudiesLiterature Surveillance

Soft Skills

LeadershipEffective CommunicationTime ManagementMultitaskingSelf-Motivation

Tools & Technologies

Veeva SafetyMS Office (Outlook, Word, Excel, PowerPoint)

Certifications & Qualifications

Pharmacovigilance CertificationDrug Safety Certification

Industry Keywords

Global PV RegulationsGVPICHFDAMHRAEMAHealth Authority InspectionsQuality AssurancePharmacovigilance SystemsCross-Functional Collaboration

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a related health field
Extensive experience in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting
Experience with safety databases (Veeva Safety preferred but not required)
In-depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and ability to implement them operationally
Strong experience with safety databases and PV systems, including configuration, validation, and maintenance
Demonstrated ability to lead and oversee PV vendors/CROs
Experience with clinical studies, postmarketing safety, risk management plans and aggregate report preparation
Track record in preparing for and supporting Health Authority inspections and audits
Strong project management skills
Relevant certifications in pharmacovigilance or drug safety are highly desirable
Advanced degree in a relevant scientific or health-related field is desirable
Experience with safety data exchange agreements (SDEAs) and literature surveillance
Ability to drive continuous improvement, process optimization, and automation in PV operations
Understanding of clinical development processes
Experience with global product launches and implementation/assessment of complex risk minimisation measures
Evidence of scientific contributions to the field
Self-motivated, with initiative and ability to take ownership and follow through
Ability to navigate multiple information sources and channels
Ability to address complex issues and recommend actions with potentially significant impact
Effective time management and organization skills
Ability to multitask and shift priorities quickly under tight deadlines
Excellent verbal and written communication skills
Strong PC experience and proficiency in MS Office (Outlook, Word, Excel and PowerPoint)