Ishika Dhingra Email & Phone Number

Mumbai, Maharashtra, India

Conducted data collection, validation, and entry of individual case safety reports (ICSRs) into pharmacovigilance databases. Performed quality checks on ICSR data to ensure accuracy, completeness, and compliance with regulatory requirements. Analyzed ICSR data using statistical methods to identify potential safety signals and trends. Collaborated with cross-functional teams including medical, regulatory, and clinical teams to address safety-related issues and implement risk mitigation strategies. Participated in pharmacovigilance audits and inspections, ensuring adherence to regulatory standards and guidelines. Conducted quality assessments of individual case safety reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory requirements. Reviewed adverse event coding, narrative documentation, and medical coding within ICSRs to identify discrepancies and inconsistencies. Provided feedback and recommendations to data entry personnel and pharmacovigilance teams to improve data quality and compliance with standard operating procedures. Conducted periodic audits of ICSR data to ensure adherence to regulatory standards and guidelines. Participated in the development and implementation of quality control processes and procedures for pharmacovigilance activities. Worked as backup lead for a team of pharmacovigilance specialists in the collection, assessment, and reporting of adverse events for assigned products. Developed and delivered pharmacovigilance training sessions for internal stakeholders. Ensured compliance with regulatory requirements and company SOPs in all pharmacovigilance activities

Strengthened relationships with colleagues by participating in collaborative projects and research endeavors. Increased academic achievement by providing one-on-one mentoring and support to struggling students. Evaluated student performance through comprehensive assessments, identifying areas of improvement and providing targeted feedback for growth. Expanded course offerings within the department by suggesting new electives based on emerging trends in academia.

Master, Pharmacy

Education record

Bachelor, Pharmacy