Group Director, PV Automation and Business Systems Solutions; PVIS

Overview

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At Roche, our Global Product Development Safety & Risk Management (PDS) department aims to enhance healthcare for patients by elucidating and communicating the safety profile of Roche medicines to optimize their benefit-risk profile. We are seeking an experienced PV systems expert to lead a global sub-function.

The Group Director leads the Pharmacovigilance Intelligent Automation and Business Systems Solutions (PVIS) sub-function, taking full business ownership of the technologies that enable global PV and safety compliance activities. This role is responsible for evaluating, implementing, and sustaining the business systems-related activities that are critical to our PV/safety processes throughout the product lifecycle. By assessing changing internal needs and the evolving external landscape, the Group Director ensures that the sub-function manages a systems solutions portfolio that remains validated, compliant and can drive continually improving business effectiveness and efficiency.

As a member of the functional leadership team within the PV & Scientific Development function, the Group Director leads a global group across 3 sites. This leadership requires a deep blend of GxP safety, scientific and business operational knowledge to support their team and aligned process experts across GVP, GCP, and devices safety. The global team ensures the infrastructure is robust enough to manage business critical activities, including exchange of individual case safety reports (ICSRs) and the provision of data for compliance oversight.

Beyond managing existing systems, the Group Director is a catalyst for business innovation. They are expected to anticipate new technological developments including process automation and opportunities to further apply artificial intelligence, in order to improve effectiveness. Success depends on building close collaborative relationships with the wider safety community, with Roche IT teams, and other internal functions to provide expert guidance on PV and safety systems and data reporting.

Externally, the Group Director will aim to be recognised as an industry thought leader, representing the company in collaborations with health authorities and industry associations. They also manage relationships with vendors and service providers to ensure ongoing support and innovation. Central to this role is the ability to inspire and empower a senior global team, fostering a culture of continuous learning/improvement and high performance while contributing to the overarching strategic direction of PDS.

• You offer a relevant degree-level qualification and 10+ years of extensive experience in the PV and clinical safety-related data, systems and reporting area. With the ability to span across Pharmacovigilance (PV) and wider science/technology disciplines (Data/Computer Science). Evidence of extensive practical application is essential.
• You bring at least 5 years of people leadership experience, with a track record of leading teams to deliver complex, cross-functional projects of high business importance/risk
• You possess expert-level knowledge of the entire technology lifecycle from ideation and design to implementation, specifically for complex solutions that drive compliance, scientific evidence generation, AI-application and/or operational improvements
• You have gained essential, hands-on experience in a safety function, mastering the collection, processing, and reporting of PV data within the context of complex regulatory legislation
• You demonstrate advanced strategic and analytical thinking, allowing you to synthesize complex information to inform decisions and create effective business…