Location
London, UK / Hybrid

Hours
Full Time

Salary
Competitive, commensurate with experience

About the Role
Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through innovative, potentially curative cell and gene therapies. Reporting to the VP Pharmacovigilance, the Senior Manager, PV Operations is a key operational leader responsible for the execution and management of global pharmacovigilance operations. This role ensures seamless delivery of case management, regulatory reporting, and operational compliance across clinical and post-marketing portfolios. Acting as the primary operational interface for PV vendors and cross-functional study teams, the Senior Manager translates functional strategy into actionable operational plans, manages complex technical issues with limited guidance, and ensures the pharmacovigilance system is robust, scalable, and inspection-ready.

Key responsibilities include leading and continuously improving global safety operations processes such as case intake, processing, and submissions in alignment with global PV regulations and company policies. The role oversees timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources and acts as the database business administrator for the Orchard safety database (Veeva Safety). The Senior Manager provides operational oversight of internal and external safety case management, including performance monitoring and quality metrics.

Additional responsibilities include strategic leadership for the selection, configuration, validation, and lifecycle management of safety systems and tools in partnership with IT and Vendor Safety Systems teams. The role leads the design, implementation, and maintenance of SOPs, work instructions, and training for safety operations. It also acts as a key technical SME supporting inspection readiness and supports internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans.

The Senior Manager liaises with Orchard Quality Assurance colleagues to ensure smooth audit programmes for internal and external pharmacovigilance system components and partners. Collaboration with safety physicians, safety scientists, and cross-functional teams ensures efficient processes and systems for high-quality data production for signal detection, aggregate safety reporting, benefit-risk assessments, and Risk Management Plans (RMPs). The role provides senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and compliance risks. It also leads operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and oversees literature surveillance workflows.

Experience
- 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 proven operational implementation.
- 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.
- Proven track record in preparing for and supporting Health Authority inspections and audits.
- Strong project management skills.

About you
- Self-motivated with initiative and ability to take ownership and follow through on tasks.
- Working knowledge of information sources and ability to navigate multiple channels to secure required information.
- Effective collaboration with cross-functional teams to address complex issues and recommend impactful actions.
- Excellent time management and organizational skills.
- Ability to multi-task and shift priorities quickly under tight deadlines.
- Excellent verbal and written communication skills.
- Strong PC skills and proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Qualifications
- Bachelor's degree or equivalent in life science, pharmacy, nursing, or related health field.
- 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 is advantageous.
- Demonstrated 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 such as peer-reviewed publications, invited presentations, guideline development, or recognized subject matter expertise in biologic safety.