Tanisha Shete
Navi Mumbai
Summary
Competent and diligent professional offering a 5 years 9 months of experience in pharmacovigilance sector, currently working as a senior drug safety associate in Cognizant Technology Solutions. I've worked with various types of projects and have mastered multiple Pharmacovigilance areas such as Aggregate reports, Signal detection, Case processing of E2B & non E2B, Training management and maintaining client relationships.
Overview
6
6
years of professional experience
Work History
Senior Data Analyst/Subject Matter Expert
Cognizant Technology Solutions
Mumbai
07.2019 - Current
- Draft aggregate reports (PBRER) within the allocated timelines.
- Formulating strategy for safety issues and response to health authority requests and integrating benefit-risk evaluation.
- Identify risk, develop search strategy and get endorsed by MR.
- Request data required to draft different sections of PBRER and review for accuracy.
- Evaluation of line listings.
- Compile non-safety sections of PBRER with respective stakeholder's input.
- Responsible for global and local Literature screening.
- Review and finalize literature to be included in PBRER and get endorsed by MR.
- Comment resolution of MR review and quality review and finalize the report.
- Worked on signal detection and validation.
- Performing initial evaluation/triage, duplicate search and book- in of cases in the database and routing cases to appropriate workflow.
- End to end case processing, which includes initial seriousness assessment, MedDRA coding, causality assessment, labeling and prioritization of daily workflow.
- Processing of serious/non serious adverse events to ensure accurate and consistent data entry with emphasis on timelines and quality.
- Total experience of processing of all report types such as Literature, clinical trial, spontaneous and patient support program.
- Assessing adverse event reports for seriousness, causality and unexpectedness as per applicable labeling and by consulting Medical Safety Physician whenever needed.
- Provide guidance and training to pharmacovigilance staff on quality standards and regulatory compliance.
Education
Bachelor In Pharmacy -
Gahlot Institue of Pharmacy
Mumbai University08.2019
Skills
- LSMV Data base
- Argus Database
- Public Relations
- Teamwork
- Time Management
- Leadership
- Effective Communication
Languages
English (Fluent)
Marathi(Fluent)
Hindi (Fluent)
Accomplishments
- Awarded Spotlight award on Dec 2019
- Awarded Coral Award on 20 Aug 2020
- Awarded Coral Award on 24 Dec 2020
- Awarded Bronze Award on 09 Aug 2021
- Awarded Sapphire Award on 29 Dec 2021
- Awarded Coral Award on 04 Aug 2022
- Awarded Coral Award on 22 Jun 2023
- Awarded Leadership Award on 16 Dec 2023
- Awarded for best productivity and exceeding support by Cognizant client on 18 Jan 2025
ADDITIONAL ACTIVITIES
Subject Matter Expert: Introduce new team members to pharmacovigilance databases and safety reporting systems.
Share best practices for data entry, such as standardised coding of adverse events and medical terminology.
Conduct regular quality checks on the work of mentees, offering constructive feedback and guidance for improvement.
Foster a culture of continuous learning by sharing updates on pharmacovigilance guidelines, regulatory changes, and industry trends.
I actively participated in trainings, meetings, and refreshers within the team, focusing on conventions and updates related to processes in pharmacovigilance.
Additional Information
SOFT SKILLS
Possesses strong computer skills, including the ability to create templates presentations, excel and work with safety database application
Shows the ability to work independently and under pressure while exhibiting initiative,
flexibility, and effective leadership abilities.
Has strong technical and problem-solving skills, with a self-motivated and proactive approach to work
Timeline
Senior Data Analyst/Subject Matter Expert
Cognizant Technology Solutions
07.2019 - Current
Bachelor In Pharmacy -
Gahlot Institue of Pharmacy