Global Patient Safety Operations Leader, Medical Devices

F. Hoffmann-La Roche AG; Welwyn; On-site; GBP 70,000 - 110,000; Full time

Job summary

Roche seeks a strategic safety professional to lead the operational oversight of ICSR and medical device safety reporting within a global team. You will drive compliant, high-quality data outputs and oversee cross-functional workflows in line with evolving regulatory standards.

This role emphasizes agile leadership, vendor oversight, and opportunities to implement AI-enabled solutions that enhance safety data delivery across the portfolio, while aligning with ISO 14155, ISO 20916, 21 CFR

Qualifications

• Degree in a relevant field; postgraduate degree strongly desired.
• Minimum 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(2017/745), EU IVDR(2017/746)).
• Proven track record in project management, vendor oversight, agile squad leadership, and influencing stakeholders across complex organizations.
• Experience or strong interest in leveraging emerging technologies, such as Artificial Intelligence, for safety data delivery and quality oversight.

Responsibilities

• Drive oversight of ICSR and medical device safety report processing to ensure compliance, quality, and alignment with regulatory standards and internal scientific requirements.
• Oversee Global Performance & Vendors: Monitor workload, quality, and KPIs across global footprint and vendor partnerships, driving inspection readiness and continuous process improvement.
• Lead Complex Projects & Process Innovation: Lead process improvements, and contribute to automation and AI innovations.
• Manage Regulatory & Legislative Change: Impact-assess revised safety legislation and lead process adaptations and training across the value chain.
• Collaborate Globally: Build strong cross-functional networks across global teams, acting as a Subject Matter Expert and escalation point for safety case processing governance.

Skills

Project management

Vendor oversight

Agile leadership

Cross-functional collaboration

Strategic thinking

Education

Postgraduate degree (PhD/PharmD/MSc/MD)

PV qualification strongly desired

Job description

Roche seeks a strategic safety professional to lead the operational oversight of ICSR and medical device safety reporting within a global team. You will drive compliant, high-quality data outputs and oversee cross-functional workflows in line with evolving regulatory standards.

This role emphasizes agile leadership, vendor oversight, and opportunities to implement AI-enabled solutions that enhance safety data delivery across the portfolio, while aligning with ISO 14155, ISO 20916, 21 CFR