Senior Research Scientist

Role & responsibilities

• Perform duplicate checks, triage, and accurate data entry of Individual Case Safety Reports (ICSRs) in accordance with applicable guidelines.
• Conduct quality control activities, including product and event coding (MedDRA/WHO-DD), narrative writing, and assessments of expectedness and causality.
• Review and validate follow-up requests to ensure completeness and compliance, and ensure timely submission of cases to global regulatory authorities.
• Allocate and distribute cases effectively while managing workflow to meet regulatory timelines and internal KPIs.
• Ensure strict adherence to global pharmacovigilance regulations, company policies, and internal SOPs.
• Provide mentoring, training, and ongoing guidance to team members to support skill development and maintain high quality standards.
• Support audits, inspections, and process improvement initiatives as required.
• Perform additional tasks as assigned by management.

Preferred candidate profile

2-3 years of hands-on experience in Pharmacovigilance / PV Operations