Safety Data Acquisition & Partnering Lead

F. Hoffmann-La Roche AG; Welwyn; On-site; GBP 90,000 - 120,000; Full time

Job summary

Roche in Welwyn Garden City seeks a Lead Clinical Study Safety Integration professional to shape pharmacovigilance data workflows and study setups. You will act as SME across global matrix teams, driving safety data intake, regulatory alignment, and continuous improvement in data processes.

On-site role requiring 51% attendance at Welwyn site with flexible remote working and up to 20% travel. You will mentor cross-functional squads and represent safety acquisition needs in internal forums.

Qualifications

• Degree-level qualification in a scientific, healthcare, or related life sciences discipline.
• Substantial experience in pharmacovigilance, with specialised expertise in safety data collection requirements.
• Proven background in clinical study setup and clinical data management, with hands-on experience incorporating pharmacovigilance requirements.

Responsibilities

• Act as SME to incorporate drug safety requirements into clinical study setups, data management protocols, and medical device frameworks.
• Design, optimise, and oversee global clinical safety data workflows and processes.
• Establish KPIs, quality controls, and metrics to monitor safety data flow and ensure inspection readiness.
• Build networks across Clinical Operations, Data Management, Regulatory, Safety Risk Management, and Affiliates to influence stakeholders.
• Coach cross-functional squads and represent SDAP in cross-functional forums.

Skills

Pharmacovigilance

Data intake

Clinical data management

Cross-functional leadership

Education

Degree-level qualification in life sciences

Tools

PV databases

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

In Patient Safety Operations, our Safety Data Acquisition & Partnering (SDAP) team establishes the vital frameworks through which safety data enters our organisation, driving regulatory compliance and scientific insights to protect patients globally. As trusted Safety partners across Roche, we pioneer innovative safety data acquisition strategies and deliver high quality safety agreements. We thrive in a complex, evolving landscape by pragmatically solving challenges, challenging the status quo and leveraging strong cross-functional networks. In this role, you will lead clinical safety data acquisition, serving as the go-to expert collaborating across global matrix teams to shape clinical study setups / acquisitions and safety operations.

Lead Clinical Study Safety Integration

Act as the go-to subject matter expert to incorporate drug safety requirements directly into clinical study setups / acquisitions, data management protocols, and medical device / combination product frameworks.

Drive Process Excellence & Innovation

Design, optimise, and oversee global clinical safety data workflows- continuously challenging the status quo to establish agile, compliant, and high-quality data intake across dynamic regulatory environments.

Oversee Performance & Quality Control

Establish KPIs, quality controls, and metrics to monitor clinical safety data flow, exercising pragmatic problem-solving to forecast bottlenecks and maintain continuous inspection readiness.

Leverage Cross-Functional Networks

Build and utilise strong networks across Clinical Operations, Data Management, Regulatory, Safety Risk Management, and Affiliate offices to influence stakeholders and drive end-to-end trial alignment.

Coach, Inspire & Present

Serve as a functional subject matter expert (SME) - coaching cross-functional squads, representing SDAP in cross-functional forums, and fostering a collaborative, quality-driven culture.

Who You Are

You are a collaborative pharmacovigilance professional with extensive expertise in safety data intake and/or clinical safety data management, seeking to drive process innovation in a global matrix environment.

Education

Degree-level qualification in a scientific, healthcare, or related life sciences discipline.

Pharmacovigilance & Data Intake Expertise

Substantial experience in pharmacovigilance, with specialised expertise in safety data collection requirements, data intake channels, and global PV operational standards.

Clinical Trial Safety & Data Integration

Proven background in clinical study setup and clinical data management, with hands-on experience incorporating pharmacovigilance requirements directly into clinical trial execution frameworks and data protocols.

Pragmatic Ownership & Scope

Proven ability to deal pragmatically with complex and ambiguous operational scenarios, acting as the recognised go-to owner and subject matter expert for assigned clinical safety data deliverables.

Process Innovation & Data Workflows

Proactive drive to continuously challenge the status quo, questioning existing practices to optimise clinical data workflows and enhance data flow efficiency across the broader pharmacovigilance ecosystem.

Cross-Functional Influence & Networking

Strong interpersonal capabilities with a demonstrated track record of building trust quickly across diverse teams and engaging cross-functional partners to navigate complex workflows.

Subject Matter Leadership & Communication

Established SME capability with direct experience presenting complex safety data topics in cross-functional forums and effectively representing safety acquisition requirements to internal and external operational partners.

Medical Device & Combination Products (Preferred)

Experience or familiarity with medical device and combination product safety data requirements is a plus, alongside core pharmaceutical drug experience.

On-Site & Flexible Working

Ability to work from our Welwyn Garden City site at least 51% of the time (approximately 2.5-3 days per week), balancing in-person team collaboration with flexible remote working.

Mobility

Willingness to travel internationally as required (approximately 10-20%).

Who we are

Together, we'll advance along the whole patient journey with the aspiration to prevent, stop and cure diseases.

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd.

At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.

We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients' lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world

We are Roche.