mvmsalman.786
About Candidate
Location
Education
Pharmacy/Pharmacovigilance/Regulatory affairs
Work & Experience
• Supported regulatory compliance activities in accordance with FDA, EMA, MHRA, ICH, and GVP requirements. • Reviewed regulatory source documents and ensured accurate extraction of product, patient, event, and medical information. • Performed end-to-end processing of Individual Case Safety Reports (ICSRs) while maintaining regulatory quality standards. • Ensured complete and compliant safety documentation within defined regulatory timelines. • Applied MedDRA terminology and WHO Drug Dictionary coding following global regulatory standards. • Supported safety labeling consistency by identifying discrepancies between source documents and safety databases. • Assisted with regulatory documentation required for health authority submissions and inspection readiness. • Conducted reconciliation activities and quality checks to ensure compliance with pharmacovigilance regulations. • Collaborated with global regulatory, quality assurance, medical review, and pharmacovigilance teams. • Maintained SOP compliance, documentation integrity, audit readiness, and data confidentiality. • Consistently achieved SLA, quality, productivity, and compliance targets.
• Supported regulatory compliance through accurate processing of safety reports and documentation. • Performed case intake, validation, duplicate detection, and registration following global regulatory procedures. • Processed Individual Case Safety Reports (ICSRs) in accordance with ICH-GCP and GVP requirements. • Prepared regulatory-compliant safety narratives and maintained complete case documentation. • Applied MedDRA and WHO Drug Dictionary coding standards for medical events and medicinal products. • Assisted in regulatory inspections and internal quality audits through accurate documentation practices. • Ensured compliance with company SOPs, quality standards, and global pharmacovigilance regulations. • Delivered high-quality regulatory documentation within established turnaround times.
• Dispensed prescription medications accurately while ensuring compliance with pharmacy regulations and organizational SOPs. • Reviewed prescriptions for accuracy, dosage, contraindications, drug interactions, and therapeutic appropriateness. • Counseled patients on medication usage, dosage, storage, adverse effects, and adherence to therapy. • Maintained complete and accurate patient medication records and pharmacy documentation. • Managed inventory, procurement, storage, and expiry monitoring of pharmaceutical products. • Handled controlled medicines according to regulatory requirements and maintained required documentation. • Achieved high standards of customer service while maintaining dispensing accuracy and efficiency.