QCM TrackWise
Debpratim Chakraborty
Vigilance Reporting Specialist
Hyderabad,TG
Summary
I want to excel my works, under professional guidance and achieve organizational goals. Seeking quality environment where my knowledge can be shared and enriched. Looking for an opportunity where I can improve my works and Quality Environment.
Offering strong organizational abilities and keen interest in safety and compliance, eager to learn and develop in this environment. Contributes understanding of safety procedures and regulations, along with skills in hazard identification and risk assessment. Ready to use and develop communication and analytical skills in Regulatory Professional role.
Positive, detail-focused individual with knack for understanding safety regulations and procedures. Possesses foundational knowledge of hazard identification and risk assessment, alongside skills in implementing safety protocols and performing safety audits. Committed to creating safer work environment and reducing workplace incidents.
Overview
3
3
Certificate
3
3
Languages
4
4
years of professional experience
5
5
years of post-secondary education
Education
MBA - Operations
Symbiosis Institute of Management Studies
Pune, India 08.2023 - Current
B. Pharma - Pharmacy
West Bengal University of Technology (WBUT)
Kolkata, India 08.2016 - 07.2020
Skills
Vigilance Reporting
Timeline
MBA - Operations
Symbiosis Institute of Management Studies
08.2023 - Current
Senior Safety Associate
4c Pharma Solutions
12.2022 - Current
Senior Associate
Wipro Digital Operations and Platforms
09.2020 - 12.2022
B. Pharma - Pharmacy
West Bengal University of Technology (WBUT)
08.2016 - 07.2020
Work History
Senior Safety Associate
4c Pharma Solutions
12.2022 - Current
- Vigilance Reporting Submission to US FDA, EU, Australia, Canada, ROW
- Processing of adverse event reports from Spontaneous, Health Authority, License Partner, Patient Oriented Program, Post Market Surveillance
- Experienced in data entry and investigates customer complaints, makes initial reporting decisions, facilitates investigations and ensures consistency and completeness of the documentation for complaints
- Responsibility for day-to-day processing complaints from all Global locations
- Ensure complaints are processed thoroughly and timely in compliance with departmental procedures
- Perform preliminary classification of complaints, follow up with customers for required information and product returns, maintain complaint records and all supporting documentation, assign additional actions as necessary to close complaint
- Training the new joiners and acting as SME for the process specific queries
Senior Associate
Wipro Digital Operations and Platforms
09.2020 - 12.2022
- Medical devices vigilance regulatory FDA, EU, Australia, Canada and ROW reporting/submission
- Knowledge of FDA Mapping to code Clinical Sign and Symptoms, Device Problem and other Investigation Finding Codes
- Well-versed in TrackWise, Salesforce,SAP, E-submitter and other tools required for regulatory submission
- Submission of ICSRs daily to FDA with 100% quality and productivity
- Complaint handling and Post Market Surveillance
- Trained and supported new team members, maintaining culture of collaboration.
- Collaborated with cross-functional teams to drive successful completion of complex projects within deadlines.
Certification
Arena Animation Uttarpara, Certificate in Graphic Designing, Adobe Photoshop, Adobe Illustrator, CorelDraw, Certificate in Audio-Video Editing and After Effects, Adobe Premiere Pro, Adobe After Effects, Adobe Audition
Software
Microsoft Word
Microsoft Excel
Microsoft Powerpoint
Adobe Photoshop
Adobe Premiere Pro
Languages
Bengali
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
Hindi
Advanced (C1)
Profile Summary
Medical Device Post Market Surveillance, FDA ICSR SUBMISSION, Medical Device Regulatory Reporting, Medical Device Remediation,
Hobbies
1. Photography
2. Music
HOBBIES
MUSIC
Total Experience
4 Years 5 months
Personal Information
- Date of Birth: 10/28/98
- Gender: Male
- Marital Status: Single / Unmarried
Profile Summary
Medical Device Post Market Surveillance, FDA ICSR SUBMISSION, Medical Device Regulatory Reporting, Medical Device Remediation,
Hobbies
1. Photography
2. Music
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