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The PositionThe Opportunity
Are you a PV expert with technology experience who thrives at the intersection of data, cutting-edge software, and patient safety? We are looking for a hands-on subject matter expert to manage and advance our global systems and solutions.
As a member of our Pharmacovigilance Intelligent Automation and Business Systems (PVIS) sub-function, you will be the technical and domain expert driving and supporting our PV process and technology roadmap. From evaluating intelligent automation to ensuring compliance throughout the product lifecycle, your blend of business and technical expertise will directly safeguard global patient safety and regulatory excellence in the management of our systems and tools.
Partner in portfolio management: Drive business-side responsibilities for the evaluation, configuration, implementation, and maintenance of our global PV/Drug Safety systems.
Innovate and automate: Assess evolving scientific, regulatory, and business needs across PV to identify, test, and deploy intelligent automation and breakthrough tech solutions into daily ways of working.
Blend process with technology: Ensure new tools and systems land smoothly and efficiently for launches into operations, supporting safety-related activities across the entire product lifecycle.
Champion system validation: Take business accountability for maintaining the validated state of PV systems, ensuring strict compliance with Computer System Validation (CSV) policies and data requirements.
Support critical infrastructure: Ensure safety systems effectively support high-stakes compliance activities, including Individual Case Safety Reports (ICSRs) and signal management processes.
Advance data analytics: Facilitate partner reporting and advanced PV compliance data analytics to ensure our systems remain robust and future-proof.
Who You Are
A PV domain expert: You bring deep, specialised knowledge of Pharmacovigilance workflows and a strong understanding of drug safety business capabilities.
A technical systems specialist: You have a proven track record of configuring, implementing, and maintaining complex GxP/PV software portfolios, with a passion for bringing automation into business-critical processes.
A CSV and data integrity advocate: You have practical experience with Computer System Validation (CSV) processes and keep fast-moving technologies continuously compliant.
A cross-functional collaborator: You excel at bridging the gap between technical infrastructure and business needs, partnering seamlessly with global process owners, IT teams, industry associations, and regulators.
An evolution driver: You want to be part of a forward-thinking environment where you have the space to test new solutions, develop your skills, and truly optimize global systems.
Purpose-driven: You are ready to blend deep scientific purpose with advanced technological innovation in a positive, collaborative, and inclusive global workspace.
Location
This position is based in Welwyn, UK.
Relocation Assistance is not available.
#MQRS.
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.
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.
