Sourav Kangsha Banik
Summary
Ambitious and detail-oriented life science professional with 5+ years of experience in Post Market Surveillance focused on maximizing success through the effective use of a quality mindset and logical thinking while being a great team player.
Overview
4
4
Languages
1
1
Certification
5
5
years of professional experience
Work History
Sr Executive, Product Surveillance
Vantive
Gurugram
09.2025 - 07.2026
- Presented periodic updates to country-specific Quality Assurance Lead (EMEA) and stakeholders, tracking complaints data and escalating trends from the complaints database.
- Supporting manufacturing sites with thorough investigations, closing customer complaints, analysing trends and CAPA implementation.
- Audit support by maintaining the audit schedule, preparing internal audits with necessary documentation, assisting audit teams, and ensuring the follow-up actions completed.
- Reviewed and analyzed adverse event reports, prepared and submitted MDR, MIR, MDPR reports in compliance with regulatory guidelines.
- Oversaw and submitted global regulatory reports, ensuring compliance with regulatory requirements.
- Prepare PMS documentation: PMS plans and Periodic Safety Update reports (PSUR), in accordance with EU MDR 2017/745, adhering to MDCG guidelines.
- Working as Complaint handling Representative for Global Vantive complaints, Processing complaints, conducting due diligence, launching decision trees, supporting complaint investigation and complaint closures.
- Facilitated transition from manual quality system to digital platform, automating report preparation for enhanced traceability and audit readiness.
Sr Executive, Product Surveillance
Baxter International Inc.
Gurugram
07.2021 - 09.2025
- Complaint handling for EMEA region: Creation of Parent records in TrackWise (TW); Quality Management System, performing due diligence with the respective stakeholders, supporting the manufacturing plant with the sample analysis, submission of the complaint investigation report, and timely closure of the complaint to meet regulatory guidelines.
- Working as complaint investigator for different manufacturing plants.
- Overseeing Hillrom's integration to Baxter's PMS across EMEA: Grid review processing, support in coding reported problem code, monitoring timelines of vigilance reporting (EMEA and US reportability), reporting trends etc.
- Delivered comprehensive TrackWise training sessions to complaint handlers in the EMEA region.
- Reviewing and evaluating complaints for vigilance reporting, escalation triggers, Non-Conformance Reports, associated Corrective Actions and Preventive Actions, and Supplier Corrective Action Requests.
- Supported investigations for shipping and distribution routed through the EMEA distribution centre.
- Drafting, reviewing, and submitting Manufacturer Incident Reports (MIRs) of Medication Delivery products.
- Updating and reviewing correct IMDRF coding for the vigilance reporting.
- Drafting Periodic Safety update reports (PSUR) and Post Market Surveillance Plans (PMSP) for advanced surgery products as per EU MDR guidelines.
- Retrieve and review complaint data, net promoter score data, external vigilance data, and sales data for the data collection period (DCP) with respect to PSUR writing and evaluate the safety and clinical performance of the product during the post-commercialisation phase of the product's life cycle.
- Compile and analyze data, metrics, and trends associated with complaint intake and handling processes.
- Supporting manufacturing plant quality team in the complaint investigation process.
Technical Trainee, Product Surveillance
Baxter International Inc.
Gurugram
07.2021 - 06.2022
- Evaluated complaints for reportability to regulatory body, contributing to compliance and safety oversight.
- Evaluating complaints for reportability to the Pharmacovigilance team/ Global Patient safety unit.
- Identify trends associated with product complaints and promptly escalate findings to senior management for appropriate action.
- Collaborated with manufacturing plant, third-party supplier, and country-specific quality assurance teams to complete thorough complaint investigations, enhancing product safety and quality.
- Handled complaints for EMEA region, ensuring timely resolution and compliance with regulatory standards.
Education
KGI Certificate Program in Biosciences - Healthcare
Biocon Academy
Bangalore, Karnataka05-2021
Master of Science - Life Science and Bioinformatics
Assam Central University
Silchar, Assam01-2019
Bachelor of Science - Life Science, Zoology
SriKishan Sarda College
Hailakandi, Assam01-2017
Skills
- Quality oversight
- Post-market surveillance
- Vigilance reporting
- Complaint investigation
- Audit preparation
- TrackWise
- Power BI
- Data modelling
- SAP
- Project Management
- Third Party complaints management
- ECM complaints management
- Advanced Excel and Microsoft Office
- Microsoft Copilot
- Stakeholder Management
- Critical Thinking
- CAPA implementation
- Risk assessment
Languages
English
Hindi
Bengali
Assamese
Personal Information
Notice Period: 2 Months
Certification
- Biocon-KGI Certificate in Biosciences
- Lab Scale and Pilot Scale fermentation training in Biozeen.
- Medical Device regulation (MDR): Intro for device designers: Platform Udemy
- Medical devices Process Validation: ISO 13485. IQ OQ PQ: Platform Udemy
- Medical devices regulations 2017/745 EU: regulatory affairs: Platform Udemy
- Microsoft Power BI Desktop for Business Intelligence.
Accomplishments
- Baxter Employee of the Q1 2025, Global Post market surveillance (Baxter-Hillrom integration)
- Baxter Courage award 2024.
- Baxter Courage aware 2024: Taking responsibilities shipping/distribution investigation EMEA distribution center.
Custom
I hereby declare that the above information provided is true to the best of my knowledge and belief.
Timeline
Sr Executive, Product Surveillance
Vantive
09.2025 - 07.2026
Sr Executive, Product Surveillance
Baxter International Inc.
07.2021 - 09.2025
Technical Trainee, Product Surveillance
Baxter International Inc.
07.2021 - 06.2022
KGI Certificate Program in Biosciences - Healthcare
Biocon Academy
Master of Science - Life Science and Bioinformatics
Assam Central University
Bachelor of Science - Life Science, Zoology
SriKishan Sarda College