Global PV Process Owner & Operations Lead

F. Hoffmann-La Roche AG; Welwyn; On-site; GBP 90,000 - 130,000; Full time

Job summary

Roche Products Ltd. is seeking a Central Operations Principal to drive end-to-end safety regulatory data delivery within Patient Safety Operations. You will own processes for DSURs and PBRERs across Roche products and partnerships, coordinating cross-functional teams globally.

Leading strategy, governance, and inspection readiness, you will collaborate with Clinical Operations, Regulatory, Biometrics/Data Sciences, and Quality while managing vendor performance and process improvements.

Qualifications

• Education: Life sciences degree; postgraduate PV qualification preferred.
• Industry experience in pharmacovigilance or pharma development.
• Deep understanding of DSURs and PBRERs and clinical trial data.
• Experience representing processes in regulatory inspections/audits.
• Strong leadership, matrix management, and cross-cultural collaboration.

Responsibilities

• Oversee end-to-end regulatory reporting delivery and support cross-functional reviews.
• Lead process improvement, optimize sourcing, and reduce lead times while maintaining quality.
• Establish governance and monitor KPIs; oversee vendor delivery and performance.
• Serve as POC for regulatory inspections and audits with Global Process Owners.
• Collaborate with Clinical Operations, Regulatory, Medical Affairs, and Quality across functions.

Skills

Leadership & Mindset

Matrix Leadership

Cross-functional collaboration

Process Improvement

Strategic thinking

Education

Degree in life sciences

Postgraduate qualification (PhD/PharmD/MSc/MD) or PV qualification

Job description

Roche Products Ltd. is seeking a Central Operations Principal to drive end-to-end safety regulatory data delivery within Patient Safety Operations. You will own processes for DSURs and PBRERs across Roche products and partnerships, coordinating cross-functional teams globally.

Leading strategy, governance, and inspection readiness, you will collaborate with Clinical Operations, Regulatory, Biometrics/Data Sciences, and Quality while managing vendor performance and process improvements.