Argus
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
2023.01 - 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
2021.11 - 2023.01
- 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
2020.02 - 2021.11
- 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
2017.11 - 2020.02
- 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 2001.04 -
Skills
Team Management
undefinedSoftware
ArisG
Veeva Vault
Timeline
Operation Team Leader
PQE Group
2023.01 - Current
Patient Safety Specialist
Icon Plc
2021.11 - 2023.01
Safety Data Analyst
Covance
2020.02 - 2021.11
Junior Data Analyst
Cognizant
2017.11 - 2020.02
Bachelor of Pharmacy - Pharmaceutical Sciences
West Bengal University of Technology
2001.04 -
Similar Profiles
Danrley M. F. LimaDanrley M. F. Lima
CSV Consultant at PQE GroupCSV Consultant at PQE Group
Nitin choudharyNitin choudhary
Sr.CSV Consultant at PQE GroupSr.CSV Consultant at PQE Group
Rajasree BhattacharjeeRajasree Bhattacharjee
Talent Acquisition Specialist at Pharma Quality Europe (PQE) GroupTalent Acquisition Specialist at Pharma Quality Europe (PQE) Group