Harshad Chaudhari

About Harshad Chaudhari

As an adaptable Pharmacovigilance Specialist, I bring a wealth of experience in adverse event reporting, regulatory compliance, and risk management within the pharmaceutical industry. My proven track record reflects a commitment to meticulous attention to detail, effective team collaboration, and an unwavering dedication to ensuring the highest standards of pharmacovigilance practices.Expertise:In-depth knowledge of pharmacovigilance regulations and global compliance standards has been a cornerstone of my career. Proficient in safety databases such as ArisG, and Argus, I have overseen the processing and reporting of over adverse events, implementing quality checks that resulted in a 20% error reduction. My expertise extends to medical coding (MedDRA), successful training initiatives, and managing diverse drug safety portfolios.Key Achievements-Maintained a 98% compliance rate with pharmacovigilance safety reporting requirements, demonstrating a comprehensive understanding of regulatory standards-Successfully conducted a comprehensive review of over serious and non-serious adverse events, ensuring thorough and accurate assessment-Managed a high-performing team that processed 4,500 case reports within 2 months with exceptional accuracy, maintaining a 98% compliance rate-Proactively recognized and triaged adverse events, consistently meeting reporting timelines with an average response time of 24 hours.CORE COMPETENCIESPharmacovigilance Expertise | Regulatory Compliance | SOP Adherence | Medical Terminology | Data Processing | Quality Check | Adverse Event Management | Pharmacovigilance Reporting Software (Argus, ArisG)| Safety Databases Applications | Literature Search | Record Keeping |Microsoft Office | Web-based Applications | Time Management | Leadership | Communication Skills | Self-Motivation | Flexibility | Decision Making | Multi-tasking | Workflow Management | Writing SOPs | Record Maintenance | Training Delivery | Customer Service |

Experience

1. Senior Drug Safety Associate (Pharmacovigilance)

   Qinecsa Solutions

   Sep 2022 — Present · Mysore Taluka, IN

   Maintained 100% compliance with safety reporting requirements by vigilantly monitoring and reporting adverse events, ensuring regulatory adherence-Expertly managed and processed over AE cases, demonstrating meticulous attention to detail and efficiency-Enhanced PV awareness among 40 employees through tailored training sessions, ensuring a more compliant workforce-Maintained an exceptional 98% accuracy rate by implementing quality checks on safety narratives, reducing errors by 20%-Spearheaded efficient workload and task management, achieving a flawless 100% on-time completion rate, ensuring compliance-Oversaw the lifecycle of Individual Case Safety Reports (ICSRs) from 90+ countries, adhering to SOPs for reporting to Regulatory Authorities-Managed vendor audits, actively participating in case-defending sessions, resulting in successful outcomes-Implemented robust reconciliation processes, preparing and distributing accurate weekly and monthly PV reports-Demonstrated strong analytical and technical skills in optimizing source documentation, data collection, submission, and management-Established impactful refresher training programs covering pharmacovigilance functions, regulations, and quality standards, ensuring team readiness-Contributed to the development and implementation of Corrective and Preventive Actions (CAPAs) for ongoing compliance and process improvement-Maintained 100% compliance with safety reporting requirements by vigilantly monitoring and reporting adverse events, ensuring regulatory adherence-Expertly managed and processed over adverse event cases, demonstrating meticulous attention to detail and efficiency.

Education

• Savitribai Phule Pune University

  Master of Pharmacy, Pharmacology

  2015 — 2017

• North Maharashtra University

  Bachelor of Pharmacy - BPharm

  2011 — 2015