Global Patient Safety Operations Lead - Medical Devices

Roche; England; Presencial; GBP 90.000 - 120.000; Jornada completa

Descripción de la vacante

Roche is seeking a strategic safety operations leader to oversee ICSR and medical device safety data across a global footprint. You will drive process improvements, oversee vendors, and influence stakeholders while embracing AI-enabled safety data delivery.

The role requires a degree in a relevant field with postgraduate qualifications preferred and a track record in PV and medical device vigilance. You will navigate regulatory changes and lead cross-functional teams in a matrix environment.

Formación

• Degree in a relevant field; postgraduate qualification strongly desired.
• 3+ years of industry experience in medical device vigilance and pharmacovigilance operations.
• Solid understanding of global safety obligations and medical device regulations (ISO 14155, ISO 20916, 21 CFR Part 812/820, EU MDR/IVDR).
• Proven track record in leading projects, vendor oversight, agile squads, and stakeholder influence.

Responsabilidades

• Drive Operational Excellence: oversee ICSR and medical device safety report processing for compliance and quality.
• Oversee Global Performance & Vendors: monitor workload, quality, KPIs across global footprint and vendors.
• Lead Complex Projects & Process Innovation: drive process improvements and contribute to automation and AI initiatives.
• Manage Regulatory & Legislative Change: assess regulatory changes and lead process adaptations and training.
• Collaborate Globally: build cross-functional networks and act as SME and escalation point for governance.

Conocimientos

Leadership

Project management

Agile methodologies

Vendor oversight

Cross-functional collaboration

Influencing stakeholders

Educación

Degree in a relevant field

Postgraduate degree (PhD/PharmD/MSc/MD) preferred

Descripción del empleo

Roche is seeking a strategic safety operations leader to oversee ICSR and medical device safety data across a global footprint. You will drive process improvements, oversee vendors, and influence stakeholders while embracing AI-enabled safety data delivery.

The role requires a degree in a relevant field with postgraduate qualifications preferred and a track record in PV and medical device vigilance. You will navigate regulatory changes and lead cross-functional teams in a matrix environment.