Sarah Freestone Email & Phone Number

United Kingdom

Brussels, Be

Leads UCB's Global ICSR case processing activities, ensuring compliance with regulatory requirements and driving process improvements.Manages PV-related IT systems, enhancing efficiency and accuracy; drives technology roadmap development and delivery.Medical device and digital initiative vigilance and safety, including benefit risk assessment.Innovation process owner and lead.Strategic partnership management, fostering collaborations to drive innovation and improve patient safety.

Brussels, Be

Global leader of UCB's product pharmacovigilance and device vigilance and safety process and teamGlobal ICSR case processing activitiesLeads the company PV and device signal detection processesBusiness process owner for PV-related IT systemsDevice safety and vigilanceAudits and inspectionsStrategic partnership management

Brussels, Be

• Global head of pre- and postmarket safety and vigilance for medical devices, IVDs and device constituents of combination products.• Postmarket safety reporting per 21 CFR Part 4, 21 CFR Part 803, EU MDR 2017/245 (Medev 2.12)• Premarket safety monitoring (ISO14155, ICH GCP)• Establishment and ongoing monitoring of benefit-risk profiles for medical devices and device constituents of combination products (ISO14971, ICH)

Watford, Hertfordshire, Gb

• Global head of Smith + Nephew’s product quality complaint and adverse event (AE) reporting function, run as a shared service covering all S+N manufacturers and full product portfolio (Orthopaedics, Sports Medicine, Robotic Surgery, Advanced Wound Management and Ear, Nose and Throat)• Member of Smith +Nephew’s Quality and Regulatory Leadership Team• Expertise in Global medical device, EU pharma, US device-drug combination products, US biologics, complaint handling, adverse event reporting, safety reporting of clinical studies• Customer and Commercial facing role• Regular interaction with Regulatory Agencies/National Competent Authorities and Notified Bodies• Leader of large team located in various global locations• Active participation in Smith + Nephew core strategy development for Quality and Regulatory and adjacent functions• Extensive practised knowledge of Quality Systems, providing input to key decision making around Quality Holds, PRA, HHE, FSCA/recalls and CAPA, and Quality System strategy and harmonisation• 21 CFR Parts 803, 806, and 820, 822, ISO13485, ISO14971, EU MDD (93/42/EEC), EU MDR (2017/745), Canadian MDR (SOR/98-282), Japanese MHLW Ordinance 169, Australian Therapeutic Goods (Medical Device) Regulation 2002• Provide postmarket surveillance and customer feedback input and review/approval for new product development, regulatory submissions and commercial tenders• Audit front room experience with external agencies and Notified Bodies• External inspectional observation/audit response and remediation• Sponsor agreements with external markets• Outsourcing agreements with non-core functional providers• M&A due diligence and integrations• Led Smith + Nephew’s Vigilance Workstream as part of EU MDR preparation programme• Regular preparation of documents and presentations for Board of Directors• Experienced in large transformational change projects• Lean-based process improvement• Experienced at leading in stable and turnaround scenarios

Watford, Hertfordshire, Gb

• Reported to Smith + Nephew’s Chief Medical Officer• Developed and implemented a single Global process for complaint handling at Smith + Nephew• Led business team through to delivery of FDA GXP Part 11 compliant global software platform for complaint handling and adverse event reporting for medical devices• Led change management effort, including management of stakeholders and delivery of training for 17000 employees

Watford, Hertfordshire, Gb

• Reported to Smith + Nephew’s Chief Scientific Officer• Developed and implemented a global tool kit for portfolio and project prioritisation including KPIs, a project valuation methodology, a portfolio prioritisation tool, and a single global StageGate™ system• Provided a view of the company’s R+D portfolio for quarterly reporting to CEO• IP landscaping and management of corporate R+D IP portfolio• Participated in due diligence activities for M+A• Project Manager for Quality and Regulatory input for ERP optimisation project

Watford, Hertfordshire, Gb

• Reported to SVP Strategy and Business Development• Facilitated the annual strategic planning process for the Global Business Unit• Organised and facilitated strategy meetings including coordination of preparatory work flows, management of teams and management of external facilitators• Delivered strategy documentation for Smith + Nephew’s President’s Council Strategy Meetings and Board of Directors• Supported M+A activity including recommendation of business development targets, preparation of business cases for approval by the Board and due diligence activities• Managed strategic projects with external consultancy firms• Prepared content for inclusion in Smith + Nephew’s annual reports• Coordinated business risk management process

Watford, Hertfordshire, Gb

• Researched and reported key market trends and current affairs, provided insight into competitor portfolios, pricing, profit and margins, and business strategy• Supported M+A activity including recommendation of business development targets, preparation of business cases for approval by the Board and due diligence activities• Published internal quarterly competitive intelligence bulletin for the Smith + Nephew Group

Watford, Hertfordshire, Gb

• Managed Smith + Nephew’s open innovation programme for S+N’s Corporate R+D function• Managed of a programme of projects arising through open innovation networks including securing external funding through national and international government grants• Developed business cases to support projects and negotiated terms for evaluation periods with third parties• Secondment to lead Group level review of Biologics, leading to creation of a new business unit.

Watford, Hertfordshire, Gb

• Leadership of R&D projects• Developed SafeSteps™, trademarked system for assessing risks associated with human tissue and cell therapies to assist EUCOMED in making a successful amendment to the EU Medical Devices Act

Swindon, Gb

Researched the role of Sonic Hedgehog signalling in prostate development and disease.

Ph.D., Human Molecular Genetics

High Potential'S Leadership Program

Msc, Technology Management

Bsc (Hons), Genetics