Summary
Overview
Work History
Education
Skills
Software
Timeline
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Animesh  Banerjee

Animesh Banerjee

Pharmacovigilance And Quality Assurance Consultant (Team Lead)
Hyderabad

Summary

Forward-thinking team leader skilled at operating departments efficiently to meet goals. Successful background matching employees with roles for maximum performance. Proactive and hardworking individual focused on continuous operational improvement.

Overview

6
6
years of professional experience

Work History

Operation Team Leader

PQE Group
01.2023 - Current
  • Conducted regular quality audits to maintain compliance with industry standards while identifying opportunities for continuous improvement.
  • Cultivated strong relationships with key partners to facilitate collaborative problem-solving efforts aimed at boosting efficiency across the entire value chain.
  • Optimized resource allocation, managing staff schedules for maximum productivity and reduced overtime costs.
  • Enhanced team performance by providing regular training, coaching, and feedback to improve skill sets.

Patient Safety Specialist

Icon Plc
11.2021 - 01.2023
  • Reviewed adverse event source documents for accuracy and transcribed data into safety database screens.
  • Utilized ARGUS database to accurately process alphanumeric data.
  • Identified and captured information from ancillary documentation for electronic processing.
  • Generated global reports by incorporating diverse medical philosophies and healthcare delivery nuances.
  • Monitored performance metrics to ensure compliance with established standards.
  • Communicated with Line manager to coordinate ongoing projects and adhere to timelines.
  • Prioritized tasks to meet established deadlines.
  • Managed adverse event reports within drug safety databases.
  • Experience in the pharmaceutical industry with a strong understanding of pharmacovigilance and clinical research.
  • Familiarity with GPS safety system and business processes.
  • Proficient in working within highly regulated environments.
  • Skilled in drafting PVA Agreements and specialized versions of Safety Data Exchange Agreements (SDEA) for clients.
  • Strong ability to grasp new product itineraries quickly.
  • Experience with data analysis and visualization tools such as Excel, Business Objects, and Power BI.
  • Participated in committees focused on evaluating new technologies or equipment for potential impacts on patient safety.
  • Conducted thorough incident investigations, identifying root causes and implementing corrective measures to prevent future occurrences.
  • Performed safety analyses to evaluate potential risks and develop risk mitigation strategies.
  • Investigated incidents, determining root causes and implementing corrective actions.
  • Monitored workplace activities to determine compliance with safety regulations and standards.
  • Championed the use of simulation-based training exercises to strengthen healthcare team skills in managing critical situations.
  • Leveraged data analysis tools to monitor patterns in adverse events, providing valuable insights for targeted improvement efforts.

Safety Data Analyst

Covance
02.2020 - 11.2021
  • Investigated and resolved data integrity issues within databases.
  • Documented comprehensive business rules and use cases through requirements analysis.
  • Identified project constraints, assumptions, risks, and scope exclusions for documentation.
  • Provided ARISG training to enhance data management, monitored usage, and recommended enhancements.
  • Conducted training sessions on conventions and documentation standards.
  • Developed and updated Standard Operating Procedures (SOPs), job aids, and work instructions for drug safety.
  • Created and maintained safety management plans and Serious Adverse Event (SAE) reports using templates.
  • Maintained accurate records of all safety incidents, ensuring timely reporting to relevant stakeholders.
  • Developed strong working relationships with external partners such as regulators, insurance companies, and emergency services to improve overall safety performance.
  • Produced monthly reports using advanced Excel spreadsheet functions.
  • Maintained the project specific SDEA (Safety Data Exchange Agreement) master file for smooth manual submission via email and portal.

Junior Data Analyst

Cognizant
11.2017 - 02.2020
  • Managed day-to-day drug safety operations, overseeing serious adverse event (SAE) case processing and external pharmacovigilance vendors.
  • Drafted and reviewed SAE Case narratives (e.g., SUSAR, CIOMS, MEDWATCH).
  • Learnt basic in SQL Server (Oracle Database) PL/SQL for data management tasks.
  • Collaborated closely with Data Management team to resolve SAE reconciliation issues.
  • Expertise in end-to-end case processing within pharmacovigilance.
  • Contributed to reconciliation activities for streamlined operations.
  • Mentored junior staff for task completion and skill development.
  • Ensured productivity aligned with Service Level Agreements (SLAs) for project deliverables.

Education

Bachelor of Pharmacy - Pharmaceutical Sciences

West Bengal University of Technology
West Bengal
04.2001 -

Skills

Team Management

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Software

Argus

ArisG

Veeva Vault

Timeline

Operation Team Leader

PQE Group
01.2023 - Current

Patient Safety Specialist

Icon Plc
11.2021 - 01.2023

Safety Data Analyst

Covance
02.2020 - 11.2021

Junior Data Analyst

Cognizant
11.2017 - 02.2020

Bachelor of Pharmacy - Pharmaceutical Sciences

West Bengal University of Technology
04.2001 -
Animesh BanerjeePharmacovigilance And Quality Assurance Consultant (Team Lead)