Medical Reviewer

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Provide medical and operational oversight for end-to-end medical review activities supporting global pharmacovigilance. • Conduct ICSR medical assessment, submission readiness, and quality evaluation. • Oversee ICSR coding standards, ensuring consistent application of coding conventions. • Provide medical expertise and support to Benefit-Risk activities and safety strategy as delegated. • Act as an SME during internal audits, vendor audits, and regulatory inspections. • Support the development and maintenance of the medical review process.

🎯 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. • 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

🏖️ 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