NANDINI CHANDUPATLA
Northampton
Summary
Pharmacovigilance professional with a warm and friendly demeanor always! Skilled at Team management, ICSR / Case processing and PR/QC activities. Currently seeking a challenging opportunity to invest my technical and academic skills to grow with a passionate organization that utilizes my full potential and while doing so, I want to play my role with the everlasting efforts to improve the quality of life of the patient. To perform all the activities as per management requirements.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Junior Data Analyst
COGNIZANT TECHNOLOGY SOLUTIONS PVT LTD
06.2021 - 08.2023
- Receive information on adverse events, perform initial checks, and search the database to prevent duplicate entries, create a case (Book-in) in the ARGUS DATABASE
- Triage, Book-in, Full data entry, QC of safety cases - Case management activities including in literature, solicited (POP, NIS, and MAP), Spontaneous cases, HA, EVHUMAN and license partner cases received via E2B, CIOMS and MedWatch forms
- A clear understanding of Device case processing and combination products
- Sound knowledge of pregnancy-related conventions
- Hands-on experience working on prospective and retrospective-related cases and case linking
- Therapeutic areas included: Immunology, Dermatology and Cardiology
- Ensure scientific rigor through accurate and complete end-to-end data entry of all fields including the verbatim
- Narrative writing/ I-narrative summarizing case information for all safety cases
- Follow-up of safety cases as per client requirements and procedures (irrespective of source, report type and seriousness)
- Perform case corrections, deactivation, case rejection and NTBD (not to be databased)
- To perform medical coding and product coding by using WHO and MedRA
- Prepare narratives/iNarrative summarizing the essential details of the case
- Self-check of online QC tool (ICSR check), case routing and case lock/closure
- Identify clinically relevant information missing from case reports and facilitate its collection
- Perform labelling for serious and non-serious cases using CDS, USPI, CDPI and SmPC
- Evaluate and finish processing of expedited and non-expedited adverse reports, including review for completeness and accuracy
- Responsible for completion of day-to-day work and process flows within the service level agreements (SLAs)
- Assists in the training and mentorship of other case processing associates as necessary.
Education
MSc in PUBLIC HEALTH -
UNIVERSITY OF NORTHAMPTON
10.2024
DOCTOR OF PHARMACY -
PRATISHTA INSTITUTE OF PHARMACEUTICAL SCIENCES
01.2021
Skills
- Argus Safety Database handling
- MedDRA and WHO coding
- MS Office tools - Word and PowerPoint
- Handling of XML files, EVWEB and PUBMED
- Maintain knowledge of global health authority regulations and requirements
- Observation and ability to grasp faster
- Clear and effective communication skills (written and verbal) and Multi-tasking
- Decision making
- Strong attention to detail
- Determination towards work
Websites
Certification
- I have undergone a training program in PACIFIX RESEARCH on Clinical Research, pharmacovigilance, medical writing, and clinical data management.
- I cleared all modules in "GOOD CLINICAL PRACTICE" an Exam conducted by "NIDA CLINICAL TRIALS NETWORK" on 04/16/2021.
- Participated as a delegate in "WHC - World Health Congress" Held in Hyderabad (year 2018).
- Participated and poster presented on "RECURRENT OCCURANCE OF HOSPITALIZATION" in the "Indian Pharmaceutical Association" held at Rajahmundry, Andhra Pradesh (year - 2019).
Languages
English
Telugu
Hindi
Personal Information
- Father's Name: Vittal
- Mother's Name: Laxmi
- Date of Birth: 02/03/1998
- Nationality: Indian
Disclaimer
I hereby declare that the details furnished above are true and fair to the best of my knowledge.
Timeline
Junior Data Analyst
COGNIZANT TECHNOLOGY SOLUTIONS PVT LTD
06.2021 - 08.2023
MSc in PUBLIC HEALTH -
UNIVERSITY OF NORTHAMPTON
DOCTOR OF PHARMACY -
PRATISHTA INSTITUTE OF PHARMACEUTICAL SCIENCES