Priya Singh

Supported risk management and compliance governance activities within a global healthcare/pharmaceutical environment. Monitored operational processes and adherence to internal policies and governance requirements. Contributed to compliance reviews, quality monitoring, risk identification and remediation. Prepared reports and management presentations, coordinated action items with cross-functional teams, and supported process improvements to strengthen quality, compliance and operational effectiveness.

Performed quality review and validation of ICSR cases in Argus Safety, ensuring accuracy, completeness and regulatory compliance. Reviewed medical information, adverse events, seriousness, expectedness and case narratives. Conducted MedDRA coding review and medical assessment. Ensured adherence to ICH/GVP and EMA/FDA requirements. Identified quality issues, supported process improvements and collaborated with case processors and stakeholders to resolve discrepancies and ensure timely case completion.