About the role

Medical Abstractor at SME level working from home. The role involves ensuring the scientific, clinical, and regulatory accuracy of medical and safety-related content across pharmacovigilance and healthcare activities.

Key responsibilities

Ensure the scientific, clinical, and regulatory accuracy of medical and safety-related content across pharmacovigilance and healthcare activities.
Conduct comprehensive review, assessment, and validation of medical information to ensure compliance with global regulatory requirements, internal quality standards, and industry best practices.
Serve as a key medical authority by providing expert clinical judgment and guidance in the evaluation of adverse events, safety data, medical narratives, and other medically relevant documentation.
Collaborate with cross-functional teams, including pharmacovigilance, clinical operations, regulatory affairs, quality assurance, and client stakeholders, to support decision-making and maintain the integrity of medical review processes.
Interpret complex clinical data, identify potential safety concerns, ensure consistency in medical assessments, and provide evidence-based recommendations.
Contribute to process improvement initiatives to enhance quality, efficiency, and compliance within medical review operations.
Support training, mentoring, and knowledge-sharing activities for team members and stakeholders.
Assist in resolving complex medical queries and provide subject matter expertise for challenging cases.
Participate in audits, inspections, and quality reviews by offering medical and regulatory guidance.
Bridge clinical expertise with operational execution to safeguard patient safety, maintain regulatory compliance, and ensure the delivery of high-quality medical review services.

Qualifications:

Minimum 2 years of experience in medical review of ICSRs in safety databases like Veeva Safety and Argus.
Fluency in English
Graduate/Postgraduate/Doctorate degree in Medical sciences or equivalent degree
Bachelor of Medicine/MD

Your future starts here—grow, thrive, and make an impact with Cognizant.

Medical Reviewer | Pharmacovigilance Specialist | Argus/Veeva | WFH