Medical Reviewer | Pharmacovigilance Specialist | Argus/Veeva | WFH

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

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