About Me
With 10 years of pharmacovigilance experience, I ensure accurate safety data reporting through effective quality systems, clinical analysis, and process improvements. I am committed to regulatory compliance and have a solid understanding of industry standards. My track record shows I can drive efficiency, productivity, and growth, earning me a reputation as a trusted professional.
Professional Experience
Qinecsa Solutions Drug safety Scientist Apr2021 - Mar-2024
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Developed a comprehensive quality management plan to ensure compliance with regulatory guidelines, resulting in a 95% reduction in compliance issues.
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Implemented a new process workflow to minimize errors and enhance overall quality, reducing error rates by 80% and increasing productivity by 25%.
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Conducted training and quality meetings with clients, resulting in a 90% client satisfaction rate and a 40% reduction in client complaints.
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Proposed a new improvement plan, which led to a 30% increase in quality management process efficiency and a 20% reduction in costs.
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Prepared training and audit plans (internal & external), ensuring that 100% of employees were trained and equipped to follow quality processes, and the system was evaluated for effectiveness 4 times a year.
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Expand regulatory expertise on case collection and expedited reporting with regulatory agencies
Cognizant Technology Solutions Data Analyst Mar2016-Apr2021
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Processed 200 literature cases and implemented quality control measures, resulting in a 95% accuracy rate for case processing. Literature monitoring.
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Drafted aggregate reports (e.g., PBRER), ensuring compliance with regulatory guidelines and enhancing the overall quality of reporting.
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Integrated the PV trace application, enhancing functionality by 25% and improving data accuracy by 20%.
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Process adverse events and other safety information from various sources (e.g., Clinical Trials, Patient Support Programs, Market Research, literature, spontaneous reports, etc).
Quintiles India Pvt. Ltd
Assocs. Operations Specialist Sep2015-Feb2016
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Triaged and processed 250 solicited, spontaneous, and clinical trial cases in a month, ensuring accurate and timely reporting of adverse events.
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Coordinated with cross-functional teams, including medical affairs, data management, and clinical operations, to ensure timely and accurate reporting of adverse events.
Sciformix Pvt.Ltd
Jr. Safety Data Analyst Apr2014-Aug2015
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Monitored the safety of pharmaceutical drugs once they were on the market, reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements
Hemogenomics. Pvt Ltd.
QA Executive Aug2012-Apr2014
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QA documentation (draft SOP, deviation, RCA-CAPA, Shipment tracking, and Change control)
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Completed Novartis Audit without any critical error and Vendor management.
Education
2011
Utkal University
M-Pharm - (Clinical pharmacy) Bhubaneshwar, India
2009
I.G.I.P.S
B-Pharm Bhubaneshwar, India
Certifications Courses:
● Industry Program in Pharma Regulatory Affairs: Jun 2021 from Bioinformatics Institute of India
● Post Graduate Diploma in Clinical Research & Pharmacovigilance: Jul 2011 from Syncorp Clincare Technologies Pvt. Ltd.
Additional certification:
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Artificial Intelligence (AI) Tools Mastery Program- 2024 from BE10X
Skills:
Drug Safety Reporting: ICSR case processing (e.g. Literature and Clinical Trials), Literature monitoring, Quality review, Updating QMS, drafting SOP and WI, Aggregate reporting (PSUR and PBRER).
Pharmacovigilance Operation: Team management, Operational oversight, Quality assurance (QA), CAPA and deviation management, Communication and Collaboration, Performance management, providing technical expertise, and conducted Audit. Ensure appropriate Follow-up is obtained and prioritize work to ensure internal and regulatory timelines are met.