Safety Data Acquisition & Partnering Lead

F. Hoffmann-La Roche AG; Welwyn Garden City; Hybrid; GBP 70.000 - 95.000; Vollzeit

Zusammenfassung

Roche in Welwyn Garden City is seeking an experienced Safety Data Acquisition & Partnering (SDAP) lead. You will shape clinical study setups, driving pharmacovigilance data collection and cross‑functional collaboration to ensure high-quality safety data throughout global trials.

The role requires substantial PV expertise, practical data integration capabilities, and demonstrated SME leadership across Clinical Operations, Data Management, and Regulatory teams.

Qualifikationen

• Substantial experience in pharmacovigilance and safety data intake.
• Clinical trial safety and data integration expertise.
• Proven ability to own complex safety data deliverables end to end.
• Strong cross-functional collaboration and SME leadership.

Aufgaben

• Lead Clinical Study Safety integration across study setups and data management.
• Design and oversee global safety data workflows with agile processes.
• Establish KPIs and quality controls for safety data flow.
• Coordinate with Clinical Operations, Regulatory and affiliates.
• Coach teams and present safety acquisition requirements in forums.

Kenntnisse

Pharmacovigilance

Data intake

Clinical data management

Cross-functional networking

SME leadership

Stakeholder influence

Ausbildung

Life sciences degree

Jobbeschreibung

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.

Responsibilities

• 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

• 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%).

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.

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.