Nikita Vikhe
Pune
Summary
Desire to take on new challenges which will bring out the best in me as an Individual and as part of the team, bringing continuous business success Excelling to the best of my ability and eager to contribute to a dynamic team and support organizational goals.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Junior Data Analyst
COGNIZANT TECHNOLOGY SOLUTIONS
Pune
06.2022 - Current
- Experience in duplicate search, determining case validity and Case creation
- Exposure to processing of serious and non-serious Adverse event report also report types-Clinical trial, Spontaneous, non-Interventional study/Program reports
- Conducted literature searches / Literature screening to identify potential signals related to marketed products or investigational drugs/biologics
- Responsible for completion of day-to-day work process within the agreed service level agreements (SLAs)
- Effective communication with the client
Case reviewer
COGNIZANT TECHNOLOGY SOLUTIONS
Pune
06.2022 - Current
- Review and evaluate AE case information to determine required action based on and following internal polices
- Enter and code, as applicable, case data, including but not limited to event, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided by the reporter
- Code products specified as suspect or concomitant by the reporter
- Provide the narrative, as required
- Review Adverse Event (AE) report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards
- Initiate follow-up activities to obtain additional information and clarification
- Confirms event term selection and coding
- Confirms/assesses event seriousness
- Performs listedness assessment
Medical Coder
COGNIZANT TECHNOLOGY SOLUTIONS
Pune
06.2022 - Current
- Reviewed patient medical records for accuracy, completeness and compliance with coding regulations.
PV Database System
COGNIZANT TECHNOLOGY SOLUTIONS
Pune
06.2022 - Current
- Effective communication with the client in context to any discrepancies related to cases
- Experience in Report type surveillance report review on weekly basis
- Send to Study ID confirmation mail to case processing team for clinical trial cases
- Have exposure to different ALM (Application Lifecycle Management) tool
- Document all the data related to Report type surveillance report review on share point time to time
- Have worked on Argus 8.4 upgrade project
- Experience in Biannual MedDRA upgrade activity
- Preparation of MOM for daily meeting and completion of all mandatory PV trainings in a timely manner
- Adding value to business through product safety functionality
Patient Safety Associate
TATA CONSULTANCY SERVICES
Mumbai
07.2020 - 06.2022
- Worked on database as a Quality Reviewer, Triager, Cases Processor and other case management activities
- Initial evaluation and case entry of all serious adverse event (SAEs), Non-serious adverse events of special interest (AES's) in database
- Evaluation of event seriousness, causality and listedness
- Analyzed root cause data and identified opportunities for improvement.
- Performed regular audits of clinical areas to ensure adherence to best practice guidelines.
- Ensured all documentation is accurate, complete, and compliant with current regulations.
Education
Master of Pharmacy -
Pravara Rural College of Pharmacy
Pravaranagar01.2021
Bachelor of Pharmacy -
Pravara Rural College of Pharmacy
Pravaranagar01.2019
Skills
- FDA/EU/ICH/GCP guidelines
- ICSR Case Processing
- Triage of ICSRs
- MedDRA Coding
- WHO DD Coding
- Narrative Writing
- Report type surveillance
- Biannual MedDRA upgrade
- Research & Development
- Fluency in English skills, both verbal and written
Certification
- Best support of year 2023 award winner.
- Industrial training at Wochardt Ltd. Chhatrapati Sambhajinagar.
- MS CIT certification.
- Participated in NSS camp.
- Register Licensed member of Maharashtra State Pharmacy Council.
Disclaimer
This is to certify that the information submitted above is true to the best of My knowledge.
Personal Information
- Date of Birth: 01/02/97
- Gender: Female
Handsonapplicationsandtools
- Argus
- Argus 8.4 upgrade
- Cognos
- MedDRA
- ALM (Application Lifecycle Management) tool
- Sapphire
- Cara
- Microsoft office suite
Languages
English
Upper Intermediate
B2
Hindi
Proficient
C2
Marathi
Proficient
C2
Timeline
Junior Data Analyst
COGNIZANT TECHNOLOGY SOLUTIONS
06.2022 - Current
Case reviewer
COGNIZANT TECHNOLOGY SOLUTIONS
06.2022 - Current
Medical Coder
COGNIZANT TECHNOLOGY SOLUTIONS
06.2022 - Current
PV Database System
COGNIZANT TECHNOLOGY SOLUTIONS
06.2022 - Current
Patient Safety Associate
TATA CONSULTANCY SERVICES
07.2020 - 06.2022
Master of Pharmacy -
Pravara Rural College of Pharmacy
Bachelor of Pharmacy -
Pravara Rural College of Pharmacy