Medical Reviewer

About the Role ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. 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. What You'll Do

• ICSR medical assessment, submission readiness, and quality: 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.
• ICSR coding standards and conventions: 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.
• Safety surveillance support and inspection readiness: 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.
• Process leadership, vendor oversight and continuous improvement: 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. What We're Looking For
• 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.
• Experience in operational oversight and/or leading cross-functional processes, including vendor oversight and performance monitoring, desired.
• 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. Nice to Have
• Experience supporting multi-year roadmaps and transformation automation initiatives. Compensation & Benefits
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others About ICON At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.