➢ Collaborated with the development team to implement data-driven improvements to the client portal, resulting in a 40% increase in user engagement and a 25% improvement in user satisfaction ratings.➢ Assisted in the facilitation of meetings with stakeholders to gather data and feedback for portal redesign, contributing to a 20% improvement in the portal's user interface and functionality.➢ Maintained strict confidentiality in handling sensitive client information, ensuring compliance with privacy regulations, and building trust with clients.

➢ Reviewed end-to-end data management processes, including data processing, quality control, database management, and data analysis.➢ Investigated quality complaints, performed RCA (Root Cause Analysis), drafted CAPA as required, and ensured implementation of corrective actions.➢ Ensured compliance with regulatory requirements, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs) and prepared comprehensive pharmacovigilance reports (SUSARs, PSURs) for regulatory submissions.➢ Redacted patients’ personal information in received documents to ensure and maintain patient confidentiality in all communications.➢ Conducted quality checks for written narratives of clinical trial cases through assessment of respective source documents.➢ Collaborated with cross-functional teams, including clinical operations, biostatistics, and medical affairs, to ensure seamless data flow and trained junior associates in case processing.➢ Managed team for short-term projects and assisted the project manager with training and deliverables, scheduling meetings, and updating project status reports.

➢ Developed and implemented quality control processes to verify the accuracy and completeness of adverse event reports. Conducted regular audits of pharmacovigilance documentation, ensuring compliance with internal procedures and regulatory requirements.➢ Performed triage activities, following company Standard Operating Procedures, internal business practices, and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.➢ Coded relevant medical terminologies (adverse events, medical history, concomitant diseases) using MedDRA and communicating with medical advisors for causality assessments if required.➢ Executed initial triage, assessed, categorized, and prioritized case reports from clinical studies, validating the authenticity of received clinical reports and electronic case report forms (eCRFs). ➢ Proficient in using pharmacovigilance databases and software (such as Aris-g, Sapphire) for adverse event case processing, signal detection, and regulatory reporting. Ensured accurate and up-to-date data entry, facilitating efficient adverse event tracking and reporting.