Research Scientist / Senior Research Scientist

About This Role

This research scientist role involves managing the end-to-end processing of Individual Case Safety Reports (ICSRs) within global safety databases. The position requires accurate documentation, verification of safety information, and timely processing of cases while adhering to pharmacovigilance regulations.

Responsibilities

• Manage end-to-end processing of Individual Case Safety Reports (ICSRs), including case intake, triage, duplicate checks, data entry, and case management within global safety databases
• Accurately document and verify critical safety information, including adverse events, product details, reporter information, medical history, laboratory results, and case narratives in line with established SOPs
• Ensure timely processing of initial and follow-up cases while maintaining compliance with global pharmacovigilance regulations and regulatory reporting timelines
• Identify missing or incomplete information and initiate follow-up activities to obtain comprehensive and medically relevant case details
• Maintain high standards of data quality, accuracy, consistency, and compliance while achieving productivity and performance targets
• Adhere to global pharmacovigilance guidelines, company policies, standard operating procedures, and data privacy requirements
• Contribute to process improvement initiatives, team learning programs, knowledge-sharing activities, and operational excellence projects

Requirements

• Pharmacovigilance Operations
• Individual Case Safety Report (ICSR) Processing
• Safety Database Management
• Case Triage & Duplicate Detection
• Medical Data Review & Verification
• Regulatory Compliance & Reporting
• Quality Assurance & SOP Adherence
• Data Privacy & Confidentiality Management
• Process Improvement & Operational Excellence
• Cross-Functional Collaboration

Application Process

• Apply directly or share your CVs with the subject as Application for ICSR Role