Location: Chennai, India
Company: ICON plc
Department: Clinical Operations, Pharmacovigilance & Patient Safety
Job ID: JR145827
Work Model: Hybrid
Experience Required: Minimum 2+ Years Experience Required (Not for Freshers)
About ICON plc
ICON plc is a globally recognized healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, medical device, and public health companies worldwide. The organization plays a critical role in accelerating clinical development, improving patient outcomes, and advancing innovative therapies from molecule to medicine.
ICON is known for its strong global clinical research ecosystem, inclusive work culture, employee development programs, and high-impact clinical trial projects across therapeutic domains.
Job Overview – Clinical Nurse Reviewer I
ICON plc is hiring experienced professionals for the position of Clinical Nurse Reviewer I in Chennai. This opportunity is ideal for registered nurses and clinical research professionals with experience in clinical trials, endpoint adjudication, pharmacovigilance, and medical review activities.
The selected candidate will support endpoint adjudication processes, clinical documentation review, dossier preparation, adverse event analysis, and coordination with Clinical Endpoint Committees within global clinical trials.
This role offers excellent exposure to clinical research operations, medical review workflows, drug development processes, regulatory compliance, and pharmacovigilance systems.
Key Responsibilities
Review and manage clinical trial endpoint documentation for adjudication activities
Coordinate collection, quality check, and processing of endpoint source documents
Prepare medically accurate adjudication dossiers for physician review committees
Analyze medical records, laboratory findings, procedures, and clinical narratives
Support endpoint-driven clinical trials and investigational product studies
Generate and maintain adjudication status reports and tracking documentation
Collaborate with Clinical Operations, Project Management, and Physician Adjudicators
Identify potential risks related to unblinding and data inconsistencies
Extract Endpoint and Adverse Event (AE) information from source documents
Ensure proper medical coding using MedDRA terminology and clinical databases
Maintain compliance with ICH-GCP guidelines, FDA regulations, SOPs, and international clinical research standards
Required Qualifications & Skills
Registered Nurse (RN) qualification is mandatory
Minimum 2+ years of experience in clinical research, pharmacovigilance, drug safety, or clinical development
Strong understanding of clinical trial processes and endpoint adjudication
Experience with MedDRA coding and adverse event terminology preferred
Knowledge of FDA regulations, GCP guidelines, and clinical documentation standards
Familiarity with eCRFs, electronic data capture systems, and Microsoft Office tools
Excellent analytical thinking, medical interpretation, and communication skills
Strong organizational and documentation management capabilities
Ability to work in fast-paced global clinical research environments
Willingness to travel up to 10% if required
Who Can Apply?
This role is best suited for:
Clinical Research Nurses
Pharmacovigilance Professionals
Drug Safety Associates
Clinical Data Review Specialists
Medical Review Professionals
Experienced Clinical Operations Executives
Freshers are not eligible for this position as prior clinical industry or drug development experience is mandatory.
Why Join ICON plc?
Opportunity to work with one of the world’s leading CROs
Exposure to global clinical trials and multinational pharmaceutical projects
Strong career growth opportunities in Clinical Operations and Pharmacovigilance
Competitive salary and employee benefits package
Hybrid work flexibility and employee wellness programs
International work culture focused on innovation and professional development
Employee Benefits
ICON offers industry-leading employee benefits including:
Comprehensive health insurance plans
Retirement and savings programs
Paid annual leave and flexible work policies
Global Employee Assistance Programs
Life insurance coverage
Wellness initiatives and work-life balance support
Country-specific employee benefit programs
Important Note for Applicants
Candidates with experience in clinical trial operations, medical review, pharmacovigilance, endpoint adjudication, or drug safety will have a strong advantage for this role.
Professionals seeking career growth in Clinical Research, Pharmacovigilance, Drug Safety, Medical Review, Clinical Operations, and Healthcare Intelligence are encouraged to apply.
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