Kamlesh Bhagat
Dublin
Summary
Results-driven pharmacovigilance professional with 7 years of experience in drug safety monitoring and adverse event reporting. Expertise in signal detection and risk management, ensuring pharmaceutical products meet rigorous regulatory compliance standards. Proven ability to enhance pharmacovigilance processes through cross-functional collaboration and analytical proficiency. Career goals focused on advancing safety measures within the pharmaceutical industry.
Overview
9
9
years of professional experience
Work History
Retail Sales Associate
Apple Green
Dublin
04.2023 - Current
- Reduced stock shortages by 25% through weekly inventory assessments.
- Implemented a streamlined ordering process through meticulous weekly stock and supply audits, leading to a 20% decrease in stockouts and enhancing the inventory turnover rate by 15%.
- Collaborated with team members to achieve sales targets and contribute to a positive work environment.
Supply chain Intern
Bianvie
Dublin
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.
Lead safety science Specialist
LabCorp Scientific Services & Solution Pvt. Ltd.
Mumbai
03.2021 - 12.2022
- Developed a detailed checklist for quality reviews of drug safety reports, achieving a 100% 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
Mumbai
07.2018 - 03.2021
- Led a rigorous analysis of Individual Case Safety Reports (ICSRs) in the safety database, achieving a 30% improvement in adverse event tracking accuracy, and ensuring 100% compliance with labeling documents, thereby strengthening drug safety oversight.
- Expedited the processing of potential SUSAR cases, achieving 100% 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 a 30% 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
Mumbai
09.2015 - 07.2018
- Executed adverse event coding using the MedDRA 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 - Supply Chain Management
Dublin Business School
Dublin, Ireland01-2024
Bachelor - Pharmacy
Sinhgad Institute of Pharmacy
Pune, India08-2015
Skills
- Adverse Event Reporting Systems (FDA MedWatch, EudraVigilance)
- Pharmacovigilance System Master File (PSMF) Maintenance
- Signal detection and risk management
- Audit planning, execution, and vendor oversight
- Regulatory Inspection Readiness and Support
- Adverse Event (AE) Reporting and Case Management
Awards
Spotlight of the Month & Phoenix of the Month, 04/01/17, Cognizant Technology Solutions Pvt. Ltd., Awarded for exceptional productivity and quality performance, demonstrating consistent excellence and dedication to high standards.
Affiliations
Certificate in Aggregate Reporting: Earned certification in aggregate reporting, demonstrating advanced expertise in analyzing and reporting safety data for pharmacovigilance compliance.
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
Master - Supply Chain Management
Dublin Business School
Bachelor - Pharmacy
Sinhgad Institute of Pharmacy
Similar Profiles
Emma ManningEmma Manning
Deli Clerk at Apple GreenDeli Clerk at Apple Green
KAMLESH BHAGATKAMLESH BHAGAT
Retail Sales Associate at Apple GreenRetail Sales Associate at Apple Green
Azelia MorganAzelia Morgan
Starbucks barista at Apple GreenStarbucks barista at Apple Green