Dr. Shivani Mahajan
Greater Noida
Overview
16
16
years of professional experience
1
1
Certification
Work History
Key SME & Quality Lead - Digital Dentistry
Tata Consultancy Services
Noida
02.2024 - Current
- Pioneering Digital Transformation in MedTech
- Key Subject Matter Expert (SME) and Quality Compliance Lead - TCS Digital Dentistry Initiative
- Pioneering Digital Transformation in MedTech: Playing a pivotal role as a key SME in driving TCS’s inaugural venture into digital dentistry, setting new benchmarks in MedTech innovation and excellence
- Expertise in 3Shape CAD/CAM Software: Leverage extensive experience with 3Shape CAD/CAM software to optimize dental workflows, enhance precision in digital impressions, and ensure superior patient outcomes
- Quality Assurance Leadership: Ensuring all processes met rigorous industry standards, resulting in consistent delivery of top-tier digital dental solutions
- Strategic Collaboration: Working closely with cross-functional teams, including software engineers, dental professionals, and client stakeholders, to align digital dentistry solutions with market demands and client needs
- Innovation in Workflow Optimization: Developed and implemented streamlined digital workflows that reduced turnaround times and increased operational efficiency
- Client-Focused Approach: Following a client-centric approach by tailoring digital dentistry solutions to meet the unique requirements of client, thereby fostering strong, long-term relationships
- Training and Development: Provide comprehensive training sessions, whenever required, on 3Shape CAD/CAM software and quality compliance protocols, empowering teams with the knowledge and skills needed to excel in the digital dentistry space
Validation Expert
Tata Consultancy Services
Thane
02.2023 - 01.2024
- DevOps engineer with track record of optimizing software development
- Dry Run testing on Argus safety data base
- Identified issues, analysed information and provided solutions to problems
- Exceeded goals through effective prioritization and consistent work ethic
- Collaborated with team members to achieve target results
- Updated databases while complying with GDPR regulations
Team Leader
Tata Consultancy Services
Thane
11.2022 - 01.2023
- Ensuring that team performance is in line with SOPs and guidance documents
- Mentoring the trainees onto the database, SOPs, guiding documents and training mails, and assisting in resolving problems; providing technical support
- Regular telephonic interaction with client to resolve queries related to the processing of ICSRs
- Triaging of cases and ensuring proper distribution of cases among the team members
- Liaises with Manager or designee with regard to resources, timelines, and issues with quality; reorganizes daily workload based on priority; proactively communicates to management new issues; offers solutions and reports availability to take on new assignments
- Quality check of serious and non serious cases of Drugs, Cosmetic, Supplements and Device
- Maintaining high standards in managing documents to face client audit
Medical Reviewer & Medical Advisor
Tata Consultancy Services
Thane
03.2021 - 10.2022
- To provide medical inputs in terms of assessing the Event coding, assess the Seriousness and assess Causality
- To author Company Clinical Comment (CCC) for required cases that are Suspected Unexpected Serious Adverse Reaction (SUSAR)
- To review the medical sense of a case and ensure that the company point of view accurately reflected
- Provide seriousness assessment
- To serve as a point of contact for all medical related queries that case handlers might have and also to do review of individual safety cases when required
Senior Process Trainer
Tata Consultancy Services
Thane
04.2020 - 02.2021
- Resolved the queries related to Case Processing
- Updated and prepared client presentations and when required for training purpose
- Interacted with the client for queries and training purpose
- Mentored new associates in the project and monitored their quality
- Conducting newcomers training according to the role assigned and additional trainings when required (ex-refresher trainings)
Quality Reviewer (ARGUS Safety Database)
Tata Consultancy Services
Thane
07.2015 - 06.2018
- Reviewed the ICSRs for the events captured, seriousness, case priority, any product quality complaint
- Documented the errors as a record to check for the overall quality of team
- Provided feedback for the errors
- Conducted sessions for error discussion
AI-POC
Tata Consultancy Services
Thane
09.2017 - 01.2018
- As Subject matter expert and POC in automation of global safety database to improve the Process, productivity, Quality and Delivery Times of overall case processing
PV Case Receipt and Triage Specialist (ARGUS Safety Database)
Tata Consultancy Services
Thane
06.2014 - 06.2015
- Review of the source document to identify, qualify cases
- Initiation and book in data entry of each qualifying case with at least one adverse event and one suspect product
- Performing triage for seriousness
- Performing duplicate search for deciding as initial or follow up case
- Reassignment or rejection of the Non – AE case
Case Processor (ARGUS Safety Database)
Tata Consultancy Services
Thane
02.2014 - 05.2014
- Accountable for handling ICSRs for further processing after the case creation by receipt and triage
- Responsible for generating and forwarding appropriate queried and request for clarification of discrepant data or additional data
- Handling invalid cases using reference documents
- Accurate data capture of Spontaneous/ Study report
- Clinical assessments which include case seriousness
- Safety narrative writing
- Assessment of causality for Adverse Events
Drug Safety Associate
Quniesca (Bioclinica)
Mysore
03.2013 - 01.2014
Junior Lecturer
Institute of Dental Sciences
Jammu
02.2009 - 01.2013
Dentist
Bright Smile Dental Clinic
Jammu
06.2008 - 02.2009
Education
Bachelor of Dental Surgery -
RMLA University
Faizabad, UP01.2008
Certificate course - medical Tourism
Medvarsity Apollo
HyderabadPG Diploma - Hospital Administration
Medvarsity Apollo
HyderabadFellowship - Clinical Research
Medvarsity Apollo
HyderabadSkills
- Strong Interpersonal Skills
- Strategic Leadership
- Analytical Problem Solving
- Employee Development
- Effective Communication With Medical Professionals
- Effective Task Management
- Proficient in Spontaneous Speaking
- Supportive Team Collaborator
Certification
- Star Performer Award, 2016
- Star Performer Award, 2017
- Appreciation certificate from Leadership Group for AI-POC project, 01/2018
- Service and Commitment Award
Personal Information
- Date of Birth: 07/24/84
- Marital Status: Married
Disclaimer
I hereby declare that all the information given above is true to my knowledge. All the documents in original/attested copies will be produced whenever required.
Languages
English
First Language
Timeline
Key SME & Quality Lead - Digital Dentistry
Tata Consultancy Services
02.2024 - Current
Validation Expert
Tata Consultancy Services
02.2023 - 01.2024
Team Leader
Tata Consultancy Services
11.2022 - 01.2023
Medical Reviewer & Medical Advisor
Tata Consultancy Services
03.2021 - 10.2022
Senior Process Trainer
Tata Consultancy Services
04.2020 - 02.2021
AI-POC
Tata Consultancy Services
09.2017 - 01.2018
Quality Reviewer (ARGUS Safety Database)
Tata Consultancy Services
07.2015 - 06.2018
PV Case Receipt and Triage Specialist (ARGUS Safety Database)
Tata Consultancy Services
06.2014 - 06.2015
Case Processor (ARGUS Safety Database)
Tata Consultancy Services
02.2014 - 05.2014
Drug Safety Associate
Quniesca (Bioclinica)
03.2013 - 01.2014
Junior Lecturer
Institute of Dental Sciences
02.2009 - 01.2013
Dentist
Bright Smile Dental Clinic
06.2008 - 02.2009
Bachelor of Dental Surgery -
RMLA University
Certificate course - medical Tourism
Medvarsity Apollo
PG Diploma - Hospital Administration
Medvarsity Apollo
Fellowship - Clinical Research
Medvarsity Apollo
- Star Performer Award, 2016
- Star Performer Award, 2017
- Appreciation certificate from Leadership Group for AI-POC project, 01/2018
- Service and Commitment Award
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