SUMMARY * Health care professional with extensive years of experience with Pharmaceutical/Medical device industries as Medical coding and Pharmacovigilance professional in the processing and medical review/evaluation of reports related to investigational and marketed products in the following therapeutic areas: Oncology, Neurosciences, Cardiovascular, Pain/Inflammation, Rheumatology and Diagnostic products. * Responsible for the collation of safety information for aggregate reports and safety signal detection and risk management in collaboration with the Drug Safety physician. * Ensured regulatory compliance with all US and international regulations governing serious and non-serious adverse event reporting. * As a Study Lead, represented safety quality in cross-functional team meetings (such as Study Management Team) with Clinical Development, Biostatistics and Data Management etc. * Served as a Mentor and SME for fellow colleagues in project designs and product convention trainings, oversight evaluation and vendor management. * Tracked departmental regulatory reporting compliance metrics and audit findings. * Responsible for the management of all vendors providing contractual services to PV Operations, including CROs responsible for collecting and processing of serious adverse events. * Responsible for maintenance and submission of PSUR and DSUR to ensure compliance with regulatory requirements * Responsible for understanding the clinical development team on corporate safety processes and provides comments consistent with department guidelines and clinical safety issues. * Responsible for other work/functions in support of prioritized need by management and work in compliance with the Product Quality Management System (PQMS). * Strong knowledge of US FDA regulations for IND, NDA, and clinical documentation reports as per regulatory guidelines along with good understanding of medical device requirements. * A team oriented professional who works well under pressure with commitment to extracting re-search.

Highlights:

• Management
• Process Improvement
• Coding
• Regulatory Reporting
• Audit
• Cardiology
• Compliance
• Metrics
• Oncology
• Data Entry