Medical Reviewer

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.

What You Will 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.

Your Profile:

You will have a strong foundation in pharmacovigilance and drug safety, with the experience to work independently and guide others. Required qualifications and experience:

• 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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.