Medical Reviewer

ICON plc

23h • Remote

About The Position

Medical Reviewer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Medical Reviewer at ICON, you will provide medical and operational oversight for end-to-end medical review activities supporting global pharmacovigilance, including individual case safety report (ICSR) medical assessment, submission readiness for high-interest cases, and coding standards oversight. This will be a 12-month contract initially fully homebased in the UK or Belgium. This role helps develop, revise and maintain the ICSR Medical Review process and ensures consistent, timely, and inspection-ready execution aligned with global pharmacovigilance regulations and internal quality standards.

Requirements

• Experience in pharmacovigilance and drug safety within the pharmaceutical or CRO industry.
• Working knowledge of MedDRA and WHO Drug coding principles and their application to ICSR quality and reporting.
• Strong communication skills, and the ability to convey complex technical information to diverse audiences and various levels of the organization.
• Self-motivated with a proactive, problem-solving mindset and ability to drive continuous improvements and develop a diverse global PV team.
• Ability to lead, drive and execute complex projects independently.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• Experience in operational oversight and/or leading cross-functional processes, including vendor oversight and performance monitoring, desired.

Responsibilities

• Provide medical review and assessment for ICSRs as required, including targeted focus on high interest/priority cases to ensure submission readiness (e.g., completeness, medical coherence, and regulatory compliance).
• Lead assigned supplemental medical review of key cases as needed, ensuring appropriate clinical interpretation, seriousness/expectedness considerations, and consistent medical documentation in the safety database.
• Oversee ICSR coding standards, ensuring consistent application of coding conventions (e.g., MedDRA and WHO Drug as applicable) and alignment with global standards and internal guidance.
• Contribute to the development, maintenance, and delivery of PV standards, conventions, and training materials related to asset insights, medical review and coding quality.
• Provide medical expertise and support to Benefit-Risk activities and safety strategy as delegated, including collaboration with asset/candidate Benefit-Risk leads and safety physicians/scientists as applicable.
• Act as an SME during internal audits, vendor audits, and regulatory inspections, support readiness activities including evidence preparation and response development.
• Provide proactive operational management and oversight of the medical review model, including, prioritization, monitoring of adherence to timelines, and escalation of risks/issues.
• Act as point of contact (PoC) for medical review requirements across GPV Reporting Operations, Patient Benefit Risk and Medical Safety, PV Quality, and relevant cross-functional stakeholders.
• Support the development of, revision and maintenance of the medical review process, ensuring a clearly defined, documented, and scalable medical review process across clinical trial and post-marketing case processing.
• Contribute to governance with external vendors/partners for medical review activities, including performance oversight and corrective/preventive actions (CAPA) where needed.
• Partner with PV Operations leadership to ensure alignment and execution of medical review activities with broader PV operational strategy, including support for multi-year roadmaps and transformation automation initiatives.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed