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, Ireland
01-2024
Bachelor of Science - Pharmacy
Sinhgad Institute of Pharmacy
Pune India
08.2015
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
Master of Science - Supply Chain Management
Dublin Business School
Bachelor of Science - Pharmacy
Sinhgad Institute of Pharmacy
Similar Profiles
Emma ManningEmma Manning
Deli Clerk at Apple GreenDeli Clerk at Apple Green