RAKHI DASH
Greater Noida
Summary
Dynamic MDR Analyst with extensive in regulatory compliance and adverse event reporting. Proven ability in Salesforce, SAP, Trackwise and RSA for medical devices, ensuring accurate global record submissions. Strong data analysis skills complemented by effective complaint handling, driving successful outcomes in product surveillance and safety initiatives.
Overview
4
4
years of professional experience
Work History
MDR Analyst
Genpact
Gurgaon
06.2023 - Current
- In a Global complaint handling project as an Regulatory representative.
- Complete experience in Salesforce in submitting global records(both reportable and non-reportable)and EMDRs
- Also having experience in RSA coding for medical devices.
Drug Safety Associate
4c pharma
Hyderabad
12.2022 - 04.2023
- Submitted EMDRs to the FDA for both adverse events and product problems with the help of SAP, e-Submitter, WebTrader, and TrackWise.
- Focus area was Recall devices.
Production Agent (Product Surveillance)
WIPRO Technologies
Kolkata
04.2021 - 12.2022
- Worked in an USA project in collection of Devices data (Implanting, Explanting and discarded), Patient information & Physician details in Onetrack Application.(Sources were DT form, MEMO, Portal Records, NBIR etc.)
- Have experience as Complaint Owner (Follow Up, DHR creation, Medwatch, Open, IMDRF coding) and Complaint Closure using CPR Trackwise tool.
Education
B.TECH - BIOMEDICAL ENGG.
Bharath University
01.2020
Higher secondary -
United Missionary
01.2015
Seconday -
Gopandhu Vidyalaya
01.2013
Skills
- Microsoft Excel
- Microsoft PowerPoint
- Regulatory compliance
- Adverse event reporting
- Data analysis
- Matlab
- Medical device coding
- Complaint handling
Accomplishments
- GATE 2021 qualified with 409 Gate Score in Instrumentation Engineering (IN paper).
- Won 'Proud of Odisha' award from Odisha govt. in class 10.
- Gold medalist in college (2020).
Projects
Internship, Balaji Medical College and Hospital, Trainee of Medical Instruments and their operation Mini Project, Smart shoe for blinds using Arduino board Final Year Project, EMG signal, heart rate, temperature and EEG signal detection with GSM modem using microcontroller
Personal Information
Date of Birth: 08/02/98
Hobby- Travelling, music, art
Linguistic Ability
- Hindi (speak and read)
- English (speak, read, write)
- Bengali (speak, read, write)
- Odia (speak, read, write)
Timeline
MDR Analyst
Genpact
06.2023 - Current
Drug Safety Associate
4c pharma
12.2022 - 04.2023
Production Agent (Product Surveillance)
WIPRO Technologies
04.2021 - 12.2022
B.TECH - BIOMEDICAL ENGG.
Bharath University
Higher secondary -
United Missionary
Seconday -
Gopandhu Vidyalaya
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