Callum Rose

Project Lead & Vigilance Improvement Specialist

Talent

LondonMember since September 22, 2026

Systems ImprovementICH E2B R3MEDDEVGMDNGVPIMDRFLeadershipCoachingCollaboration SpecialistMulti Skilled EngineerCommunication

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Systems ImprovementICH E2B R3MEDDEVGMDNGVP

About

Results-driven, detail-oriented Project Lead & Vigilance Improvement Specialist with extensive experience delivering digital systems enhancements, data standard integrations, and regulatory solutions within healthcare and pharmacovigilance. Proven track record of managing cross-functional technical teams, engaging external stakeholders and benefit-risk assessors, and driving a 5x increase in user engagement for national regulatory platforms. Expert in bridging complex technical, scientific, and regulatory frameworks (ICH E2B R3, MEDDEV, GVP, IMDRF, GMDN) to optimise system delivery and improve patient safety outcomes.

Experience

Senior Executive Officer: Vigilance Improvement Lead at Medicines and Healthcare products Regulatory Agency (MHRA) (2025-08 – Present)

Systems Enhancement & Delivery: End-to-end management of technical and UI/UX improvements for the UK Yellow Card scheme, resulting in a 5x increase in user responses and substantially higher-quality data for safety signal evaluation.
System Integration: Led third-party software integrations into the Yellow Card architecture, establishing clear milestone frameworks and cross-organisational communications to guarantee seamless delivery.
Stakeholder Management: Fostered collaboration with software developers, regulators, and benefit-risk assessors to design and deploy automated follow-up workflows and conditional questioning modules.
Multidisciplinary Knowledge Oversee systems improvement for the UK's medicine, device, and blood reporting infrastructure, streamlining the re-processing of serious adverse reaction/event reports across multiple agencies.
Data Standards Governance: Apply deep domain expertise in international data standards (ICH E2B R3, MEDDEV) to identify structural optimizations that directly enhance patient safety data intake.
Leadership & Public Representation: Line manage and mentoring of team members on regulatory systems delivery; selected to present technical developments at the Pharmacovigilance Europe 2026 Conference.

Associate Signal Assessor at Medicines and Healthcare products Regulatory Agency (MHRA) (2023-07 – 2025-08)

Data Analysis & KPI Achievement: Assessed large-scale adverse drug reaction (ADR) datasets against tight regulatory SLAs, consistently meeting all weekly safety metrics.
Regulatory & FOI Compliance: Collaborated across teams to process and respond to complex Freedom of Information Act (FOI) requests within statutory deadlines.
Training & Onboarding: Onboarded and trained junior assessors in signal detection techniques, safety data processing, and user acceptance testing (UAT) for system upgrades.