KAMLESH BHAGAT
Dublin,Dublin
Summary
Experienced pharmacovigilance professional with over7 years in the field, specializing in drug safety monitoring, adverse event reporting, and regulatory compliance. Demonstrates a strong ability to enhance safety measures, with a track record of improving process efficiencies and maintaining rigorous compliance standards. Adept at cross-functional collaboration and leveraging analytical skills to advance pharmaceutical safety.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Retail Sales Associate
Apple Green
04.2023 - Current
- Reduced stock shortages by25% through weekly inventory assessments
- Implemented a streamlined ordering process through meticulous weekly stock and supply audits, leading to a20% decrease in stockouts and enhancing the inventory turnover rate by15%
- Collaborated with team members to achieve sales targets and contribute to a positive work environment
Supply Chain Intern
Bianvie
10.2023 - 12.2023
- Instrumental in developing a resilient supply chain network that identified four dependable suppliers, it improved overall inventory turnover rates by 15%, leading to better efficiency in meeting customer demand.
- Led a comprehensive market research initiative, identifying three key strategic partners, thereby driving a 20% increase in product availability and sales through a detailed analysis of market trends and supplier sourcing
- Assisted team members with resolving discrepancies or issues related to purchase orders, facilitating smoother transactions.
Lead Safety Science Specialist
LabCorp Scientific Services & Solution Pvt. Ltd.
03.2021 - 12.2022
- Developed a detailed checklist for quality reviews of drug safety reports, achieving a100% compliance rate in audits, and directly contributing to maintaining the organization's exemplary regulatory standing
- Managed and documented deviations, root cause analysis, and corrective/preventive actions (CAPA) to ensure timely resolution and continuous improvement of quality processes
- Successfully coordinated and implemented strategic audit plans for PV system activities, including service providers, vendors, and business partners, ensuring adherence to regulatory standards
- Played key roles in inspection readiness, including providing training, acting as an SME, and contributing to backroom and real-time inspection management for successful regulatory inspections
Pharmacovigilance Scientist
Tata Consultancy Services
07.2018 - 03.2021
- Led a rigorous analysis of Individual Case Safety Reports (ICSRs) in the safety database, achieving a30% improvement in adverse event tracking accuracy, and ensuring100% compliance with labeling documents, strengthening drug safety oversight
- Expedited the processing of potential SUSAR cases, achieving100% timeline compliance, and markedly improving case quality and patient safety
- Partnered with the Quality team to fortify vigilance and post-market surveillance strategies, leading to a30% enhancement in PSUR accuracy and punctuality
- Conducted risk assessments and identified gaps in quality systems, driving process improvements, and ensuring the implementation of corrective actions to mitigate risks
Junior Data Analyst
Cognizant Technology Solutions
09.2015 - 07.2018
- Executed adverse event coding using Medra dictionary, improving data accuracy for regulatory submissions by 25% by standardizing reporting processes
- Drafted clinical narratives for reported adverse events
- Facilitated partnerships with EU Competent Authorities, US FDA, and Health Canada
- Streamlined post-marketing adverse event reporting by adhering to SOPs, enhancing pharmacovigilance compliance, and operational efficiency
Education
Master of Science - Supply Chain Management
Dublin Business School
Dublin, Ireland01-2024
Bachelor of Science - Pharmacy
Sinhgad Institute of Pharmacy
Pune India08.2015
Skills
- Adverse Event Reporting Systems
- Pharmacovigilance System Master File (PSMF) Maintenance
- Signal detection and risk management
- Regulatory Compliance
- Regulatory Inspection Readiness and Support
- Quality Assurance and Risk Management
- Cross-Functional Team Leadership
Certification
Certificate in Aggregate Reporting: Earned certification in aggregate reporting, demonstrating advanced expertise in analyzing and reporting safety data for pharmacovigilance compliance.
Awards
Spotlight of the Month & Phoenix of the Month,2017-04-01, Cognizant Technology Solutions Pvt. Ltd., Awarded for exceptional productivity and quality performance, demonstrating consistent excellence and dedication to high standards.
Websites, Portfolios, Profiles
LinkedIn
Timeline
Supply Chain Intern
Bianvie
10.2023 - 12.2023
Retail Sales Associate
Apple Green
04.2023 - Current
Lead Safety Science Specialist
LabCorp Scientific Services & Solution Pvt. Ltd.
03.2021 - 12.2022
Pharmacovigilance Scientist
Tata Consultancy Services
07.2018 - 03.2021
Junior Data Analyst
Cognizant Technology Solutions
09.2015 - 07.2018
Certificate in Aggregate Reporting: Earned certification in aggregate reporting, demonstrating advanced expertise in analyzing and reporting safety data for pharmacovigilance compliance.
Master of Science - Supply Chain Management
Dublin Business School
Bachelor of Science - Pharmacy
Sinhgad Institute of Pharmacy
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