Anirban Mandal
Kolkata
Summary
Results-oriented Senior Drug Safety Associate with 4.8 years of experience in pharmacovigilance, adverse event reporting, and regulatory compliance. Expertise includes conducting thorough investigations, case processing, and root cause analysis to ensure patient safety and regulatory adherence. Skilled in Argus, TrackWise, and Salesforce, with a strong focus on leading teams and driving quality improvements in drug safety protocols.
Overview
3
3
years of post-secondary education
5
5
years of professional experience
Work History
Senior Complaint Handling Investigator
Wipro
Kolkata
04.2023 - 01.2026
- Domain: Diagnostic and Imaging Devices (MRI, DXR)
- Handled over 150 complaints weekly for imaging and diagnostic medical devices, ensuring timely and effective responses to customer concerns.
- Led investigations into device problems, conducting root cause analysis and documenting findings to ensure accurate resolution of medical device issues.
- Authored investigation summaries using Track Wise, clearly outlining root causes and contributing factors while recommending corrective actions.
- Utilize Salesforce, ServiceMax, One EMS and other relevant platforms to manage device problems, track investigations, and ensure timely resolution.
- Reported problem codes and problem reason codes in compliance with regulatory requirements and internal procedures.
- Expertise in ECT-ICT coding table, facilitating accurate classification of device-related problems and ensuring consistency in coding practices.
- Ensured regulatory compliance with international standards: FDA 21 CFR Part 803, EU MDR, ISO 13485, and ISO 14971.
Senior Pharmacovigilance Associate
Wipro
Kolkata
02.2021 - 04.2023
- Managed the end-to-end process of Individual Case Safety Report (ICSR) processing from multiple sources with 98% accuracy.
- Processed adverse event cases for drugs and vaccines, ensuring accuracy and regulatory compliance.
- Wrote narratives to clearly communicate clinical information and adverse event details in accordance with company standards and guidelines.
- Specialize in narrative writing and effectively communicate clinical information and adverse event details under company standards and guidelines.
- Conducted MedDRA coding of adverse events to enable standardized reporting and analysis.
- Conducted through MedDRA coding of adverse events to facilitate standardized reporting and analysis.
Education
Bachelor in Pharmacy - Pharmacy
Kanak Manjari Institute of Pharmaceutical Sciences
Rourkela , India 02.2017 - 04.2020
Skills
- Complaint Handling
- Adverse Event Reporting
- CAPA Management
- Device Complaint Investigation
- Root Cause Analysis
- Reportability assessment
- Safety reporting
- TrackWise QMS
- TrackWise
- Regulatory Frameworks
- FDA 21 CFR Part 820
- EU MDR 2017/745
- ISO 13485:2016
- PMS Activities
- MedDRA
- Argus Safety
- Team collaboration
- ECT-ICT Coding Table
Languages
- English, Professional
- Bengali, Native
- Hindi, Professional
Certifications And Achievements
Completed Industrial training from cytogene.
Timeline
Senior Complaint Handling Investigator
Wipro
04.2023 - 01.2026
Senior Pharmacovigilance Associate
Wipro
02.2021 - 04.2023
Bachelor in Pharmacy - Pharmacy
Kanak Manjari Institute of Pharmaceutical Sciences
02.2017 - 04.2020