Reporting to: VP Pharmacovigilance
Location: London, UK / Hybrid
Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative cell and gene therapies. Orchard has its global headquarters in London and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.
Job Summary
The Senior Manager, PV Operations is a key operational leader responsible for the execution and management of global pharmacovigilance operations. This role on a day to day basis ensures the seamless delivery of case management, regulatory reporting, and operational compliance across clinical and post-marketing portfolios.
This role serves as the primary operational interface for PV vendors and cross‑functional study teams. The Senior Manager, PV Operations is an emerging expert who translates the functional strategy into actionable operational plans, manages complex technical issues with limited guidance, and ensures that the "hands‑on" elements of the PV system are robust, scalable, and inspection‑ready.
Key Elements and Responsibilities
- Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies with close oversight of the pharmacovigilance vendors.
- Oversee timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources. Act as database business administrator for the Orchard safety database (Veeva Safety).
- Ensure robust operational oversight of internal and external safety case management, including performance monitoring and quality metrics.
- Provide strategic leadership for the selection, configuration, validation, and life-cycle management of safety systems and tools, in partnership with IT and Vendor Safety Systems teams.
- Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for safety operations.
- Act as key technical SME supporting inspection readiness and support internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans.
- Liaise with Orchard Quality Assurance colleagues to ensure audit programme of internal and external components of the pharmacovigilance system and partners run smoothly
- Collaborate with safety physician, safety scientist and cross-functional teams to ensure efficient processes and systems for production of high-quality data for signal detection, aggregate safety reporting, benefit–risk assessments, and Risk Management Plans (RMPs).
- Provide senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and compliance risks.
- Lead operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and oversee literature surveillance workflows.
Requirements
Education, Experience & Knowledge
Education
- Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a related health field.
- Relevant certifications in pharmacovigilance or drug safety are highly desirable.
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 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.
- Proven track record in preparing for and supporting Health Authority inspections and audits, alongside strong project management skills.
Desirable
- Advanced degree in a relevant scientific or health-related field.
- Experience with safety data exchange agreements (SDEAs) and literature surveillance.
- Demonstrated ability to drive continuous improvement, process optimization, and automation in PV operations.
- Demonstrated 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 (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety).
Skills & Abilities
· Self-motivated, with initiative and ability to take ownership of, and follow through with, specific tasks
· Working knowledge of available information sources and ability to navigate multiple channels to secure required information
· Works effectively with cross-functional teams to address complex issues and recommend actions with potentially significance impact
· Effective time management and organization skills
· Ability to multi-task and shift priorities quickly while working under tight deadlines
· Excellent verbal and written communication skills
· Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel and Powerpoint)