Safety Data Acquisition & Partnering Lead

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.

About Roche

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.

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.

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

Who we are 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.

Responsibilities

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

Requirements

• 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.
• Degree-level qualification in a scientific, healthcare, or related life sciences discipline.
• Substantial experience in pharmacovigilance, with specialised expertise in safety data collection requirements, data intake channels, and global PV operational standards.
• 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.
• 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.

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%).

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.