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
Hyderabad
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
Chennai
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
Pune
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
Kolkata
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
Team Leadership
Communication
Pharmacovigilance
Coaching & Mentoring
Cultural Sensitivity
People Development
RCA and Service level agreements
Attrition
Daily Reports
Root Cause Analysis
Staff Supervision
Software
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 -