Raghubir Kumar Mahato

About Raghubir Kumar Mahato

As a Sr. Executive in Product Surveillance, I lead the complaint lifecycle for the EMEA region, specializing in drugs, devices, and medicinal products. I ensure high data integrity within Trackwise QMS and manage EU MDR/MIR regulatory reporting and compliance.By collaborating with manufacturing plants and external suppliers, I drive technical investigations and sample retrievals. I also bridge the gap between surveillance and safety by identifying Pharmacovigilance cases and managing customer query resolutions with customer response letter (CRLs)- As a Pharmacovigilance Specialist & Certified MedDRA Coder, I deliver high-complexity ICSR management using Argus/ArisG. I expertize in triage, processing, seriousness assessment, and clinical narrative writing under GVP/ICH guidelines.Beyond case processing, I serve as a SME & Backup Team Lead, managing workflows, audit readiness, and GDP compliance. I’ve led project training and onboarding, ensuring data integrity through rigorous quality reviews and KCT-driven mentorship.

Experience

1. Sr Executive, Product Surveillance

   Baxter International Inc.

   Jul 2025 — Present · Gurugram, IN

   Global Complaint Lifecycle Management (EMEA region): Expertly manage the intake and end-to-end processing of complaints for drugs, devices, and dual-licensed medicinal products across multiple countries- QMS Expertise (Trackwise): Ensure high data integrity by accurately entering and managing complaint records within Quality Management Systems (Trackwise) in a timely, compliant manner- Regulatory Reporting & MDR/MIR Compliance: Determine reportability and draft Manufacturer’s Incident Reports (MIR) for medical devices in strict accordance with EU MDR 2017/745 and country-specific regulations- Cross-Functional Stakeholder: Act as the point of contact for External Contract Manufacturers (ECM) and Third-Party (TP) supplier’s complaints, driving the acquisition of critical investigation reports and technical data as per agreement- Manufacturing & Investigation Collaboration: Collaborating with manufacturing plants to facilitate technical evaluations, coordinate sample retrievals, timely follow ups and investigation completion- Pharmacovigilance (PV) Integration: Proactively identify potential Pharmacovigilance cases, ensuring seamless reporting to country-specific PV teams for adverse event monitoring- Customer Communications & Resolution: Draft and review high-quality Customer Response Letters (CRL) to ensure timely and professional closure of investigations- Complaint Assignment: Extract complaints data from Trackwise, prepare report and assign to the team for its owing and processing.

Education

• Dhanusha Science Campus, Janakpurdham, Nepal

  +2 (science), Science

  2012 — 2014

• Krupanidhi College Of Pharmacy, Bangalore, Karnataka

  Bachelor of Pharmacy - BPharm, Pharmacy

  2015 — 2019