Senior PV Operations & Process Owner

Roche Holding AG; Welwyn; On-site; GBP 90,000 - 130,000; Full time

Job summary

Roche is seeking a Central Operations Principal to act as the Business Process Owner for end-to-end safety regulatory data delivery within Patient Safety Operations. You will lead sourcing, preparing, and summarizing clinical trial information to produce DSURs and PBRERs across Roche products globally.

Key duties include owning end-to-end regulatory reporting, driving process improvement, governance of vendors, inspection readiness, and collaboration with Clinical Ops, Biometrics, Regulatory,

Qualifications

• Education: Degree in life sciences; postgraduate qualification such as PhD, PharmD, MSc, or MD, or formal PV qualification is strongly preferred.
• Industry Experience: Substantial experience in pharmacovigilance, pharma development, or healthcare—ideally with prior experience in business process management and global PV regulatory obligations.
• Domain & Data Knowledge: Deep understanding of DSURs/PBRERs, clinical trial design/conduct/reporting, clinical databases/management systems, statistical trial analysis and reporting, and software development lifecycle (SDLC) / systems validation.
• Inspection & Process Expertise: Direct experience representing processes in regulatory authority inspections/audits, paired with a strong track record in continuous process improvement.
• Leadership & Mindset: Forward-looking, action-oriented, and agile approach. Strong matrix management, systems thinking, negotiation, and conflict-resolution skills to drive a positive organizational culture. Extensive experience working with and managing Service Providers, and working in an international environment across cultures and timezones.

Responsibilities

• Process Ownership & Operational Delivery: Oversee and manage end-to-end regulatory reporting delivery - scheduling, setup, scope definition, data reconciliation, report generation and validation, and support of cross-functional review of final safety regulatory documents.
• Strategy, Optimization & Innovation: Propose and lead cross-functional process improvement activities. Simplifying workflow, automating, evolving sourcing strategy and driving reductions in cost and lead time - without sacrificing quality.
• Governance & Vendor Oversight: Establish robust process governance. Monitor, interpret and refine key metrics/KPIs to monitor process performance. Maintain oversight of service provider delivery.
• Inspection Readiness & Compliance: Serve as a primary Point of Contact (POC) for regulatory authority inspections and internal/partner audits. Partner with Global Process Owners (GPOs) to translate revised PV legislation into smooth operational change initiatives.
• Matrix Leadership & Collaboration: Partner with, and represent functions including Clinical Operations, Biometrics / Data Sciences, Regulatory, Medical Affairs, Clinical Science, and Quality - both at the global level and locally across the Affiliate network. Lead cross-functional teams without direct line authority.

Skills

Leadership

Matrix management

Regulatory compliance

Process improvement

Cross-functional collaboration

Education

Life sciences degree

Postgraduate PV qualification

Tools

PV systems

Regulatory databases

Data management tools

Job description

Roche is seeking a Central Operations Principal to act as the Business Process Owner for end-to-end safety regulatory data delivery within Patient Safety Operations. You will lead sourcing, preparing, and summarizing clinical trial information to produce DSURs and PBRERs across Roche products globally.

Key duties include owning end-to-end regulatory reporting, driving process improvement, governance of vendors, inspection readiness, and collaboration with Clinical Ops, Biometrics, Regulatory,