SHAYAN GHOSH
New Delhi
Summary
Experienced Medical Device Complaint Investigator and Pharmacovigilance Professional with over 5 years of experience in medical device vigilance, complaint handling, adverse event management, complaint investigation, and post-market surveillance activities. Currently working as a Team Lead in Medical Device Complaint Investigation operations, managing end-to-end complaint investigations, regulatory compliance activities, team performance, quality oversight, client interactions, and operational excellence initiatives. Possess extensive experience in global medical device regulations, complaint investigations, risk assessment, post-market surveillance, quality management systems, and stakeholder management. Strong expertise in process improvement, automation, reporting, and cross-functional collaboration.
Overview
5
5
years of professional experience
Work History
Business Analyst / Complaint Investigation Supervisor
Genpact India Pvt. Ltd.
01.2024 - Current
- Perform end-to-end complaint investigations for global medical device complaints across multiple pathways.
- Conduct complaint evaluation, investigation assessment, product analysis review, and complaint closure activities.
- Review complaint information, investigation reports, service reports, customer information, and supporting evidence.
- Perform root cause analysis and determine reportability based on available evidence.
- Evaluate product performance issues, device malfunctions, adverse events, and patient outcomes.
- Conduct complaint coding using IMDRF terminology and applicable regulatory requirements.
- Support post-market surveillance activities and complaint trending analysis.
- Review complaint investigation documentation for completeness, accuracy, and regulatory compliance.
- Coordinate with cross-functional stakeholders for additional information gathering and complaint resolution.
- Perform Good Faith Effort activities and follow-up communications when required.
- Manage day-to-day operations of Complaint Investigation teams.
- Supervise Complaint Investigators and ensure adherence to quality and productivity targets.
- Perform workload allocation, assignment tracking, and priority management.
- Conduct quality reviews and provide feedback to analysts.
- Monitor operational KPIs, SLAs, productivity, and quality metrics.
- Support onboarding, training, coaching, and mentoring of new team members.
- Drive process improvements and operational excellence initiatives.
- Manage escalation handling and issue resolution activities.
- Participate in daily operational meetings, governance calls, calibration sessions, and client review meetings.
- Conduct Weekly Business Review (WBR) presentations and operational performance discussions.
- Coordinate with client stakeholders for process clarifications, issue resolution, and operational updates.
- Participate in complaint investigation discussions and business review meetings.
- Support client audits, quality reviews, and compliance activities.
- Prepare productivity, quality, backlog, and operational performance reports.
- Develop dashboards and reports using Power BI, Excel, and SharePoint.
- Lead rework analysis and process automation initiatives.
- Support Lean Six Sigma and continuous improvement projects.
- Participate in trend analysis, risk identification, and corrective action activities.
- Create presentations, metrics reports, and management dashboards.
- Region Managed: USA, Japan, EMEA, China.
- Systems & Tools Used: GCHS, Datasweep, Salesforce, BOBJ Reports, ES-PIX, Power BI, Smartsheet, Microsoft Excel (Advanced), SharePoint, Microsoft Office Suite, Power Automate, Lotus Notes, Microsoft Teams, Outlook, M365 Applications.
Senior Associate
Wipro Ltd.
03.2021 - 01.2024
- Performed case processing and adverse event assessment activities.
- Conducted case intake, triage, medical review, and case processing activities.
- Performed literature screening and safety data review.
- Conducted follow-up activities and case reconciliation.
- Supported aggregate reporting and safety surveillance activities.
- Ensured compliance with global pharmacovigilance regulations and SOPs.
- Participated in quality checks, audits, and process improvement initiatives.
Education
Bachelor's Degree - B. Pharma
Bengal collage of pharmaceutical sciences and research
01.2020
Skills
- Medical Device Complaint Investigation
- Post Market Surveillance (PMS)
- Medical Device Reporting (MDR)
- Complaint Handling & Complaint Closure
- Adverse Event Assessment
- Complaint Triage & Evaluation
- Regulatory Compliance
- Risk Assessment & Investigation
- CAPA Support Activities
- Good Faith Efforts (GFE)
- EditIMDRF Coding
- Quality Management Systems
- Root Cause Analysis
- Complaint Trending & Signal Detection
- Team Management & Operations
- Client Communication & Stakeholder Management
- Process Improvement & Automation
- Productivity & Quality Monitoring
- Workload Prioritization
- Weekly Business Review (WBR)
- Training & Mentoring
- Data Analysis & Dashboard Reporting
- Microsoft Excel (Advanced)
- Power BI
- Smartsheet
- SharePoint
- Microsoft Office Suite
- Power Automate
- Data Analysis
- Dashboard Development
- Workflow Automation
- Reporting & Metrics
- FDA 21 CFR Part 803
- FDA 21 CFR Part 820
- EU MDR
- ISO 13485
- ISO 14971
- IEC 62304
- Medical Device Vigilance
- Complaint Handling Regulations
- Post Market Surveillance
- Risk Management
- Leadership & Team Management
- Analytical Thinking
- Problem Solving
- Client Relationship Management
- Communication Skills
- Decision Making
- Stakeholder Management
- Attention to Detail
- Time Management
- Continuous Improvement
Accomplishments
- Successfully transitioned from Complaint Investigator to Team Lead/Manager role.
- Led complaint investigation operations supporting global medical device complaint handling activities.
- Developed and implemented process improvement and rework automation initiatives.
- Improved operational productivity and quality performance through process optimization.
- Supported multiple training, ramp-up, and operational transition projects.
- Led weekly business reviews and client governance meetings with global stakeholders.
Custom Section
- FDA 21 CFR Part 803
- FDA 21 CFR Part 820
- EU MDR
- ISO 13485
- ISO 14971
- IEC 62304
- Medical Device Vigilance
- Complaint Handling Regulations
- Post Market Surveillance
- Risk Management
- Quality Management Systems
Personal Information
Languages
English
Hindi
Languages
6,C2,6,C2
Timeline
Business Analyst / Complaint Investigation Supervisor
Genpact India Pvt. Ltd.
01.2024 - Current
Senior Associate
Wipro Ltd.
03.2021 - 01.2024
Bachelor's Degree - B. Pharma
Bengal collage of pharmaceutical sciences and research