Sonali Sanjay Shinde
Thane
Summary
Accomplished literature reviewer with a strong background at TCS emphasizing quality assurance and team development. Successful in processing ICSRs and elevating client communication. Skilled in Argus Safety database and adept at resolving issues, ensuring quality and meeting team performance goals. Focused on delivering superior results in safety surveillance.
Overview
7
7
years of professional experience
Work History
Literature Quality Reviewer
TATA CONSULTANCY SERVICES- Project 1: Gilead Sciences Inc
Thane
04.2025 - Current
- Identified error findings from literature review on a monthly basis.
- Executed trend analysis for critical and non-critical errors in scientific literature.
- Conducted training sessions to enhance team quality standards.
Literature reviewer
TATA CONSULTANCY SERVICES Project 1: Gilead Sciences Inc
Thane
10.2022 - 03.2025
- Conducted literature reviews to enhance signal detection and aggregate reporting.
- Triaged full text and abstract articles, reporting findings to respective teams.
- Reviewed articles for Individual Case Safety Reports (ICSRs), identifying cases requiring creation.
- Managed client mailbox weekly, addressing inquiries and providing timely responses.
- Maintained tracker for queries related to literature work from various stakeholders.
- Mentored new associates in literature review processes, fostering skill development.
Literature case processor
TATA CONSULTANCY SERVICES-Project 2: Alkem Laboratories Limited
Thane
03.2022 - 09.2022
- Achieved high-quality processing of all ICSR types, including PMS, clinical trials, partner cases, E2B and RA.
- Elevated to Quality Reviewer position due to exceptional performance in project
Literature case processor
TATA CONSULTANCY SERVICES-Project 3: Cipla Limited
Thane
04.2021 - 02.2022
- Processed literature cases within Argus Safety to ensure compliance with regulatory standards.
- Evaluated four valid criteria of ICSRs, including AEs and product attribution.
- Completed comprehensive narrative writing for clarity and accuracy in reporting.
Junior Data Analyst
COGNIZANT TECHNOLOGY SOLUTION-Project: Sanofi Pasteur
Thane
06.2018 - 02.2021
- Possessed over two years of experience with Argus Safety Database.
- Specialized in vaccine post-marketing surveillance and clinical trial ICSRs, including literature cases.
- Trained new joiners on clinical trial and post-marketing surveillance ICSR processes.
- Served as correction SPOC, managing corrections from affiliates, partners, and internal sources.
- Maintained high-quality standards to prevent critical errors and support team performance targets.
Education
BACHELOR OF PHARMACY (B. PHARM) - Chiplun, Maharashtra
Govindaro Nikam College of Pharmacy
Chiplun, Maharashtra06-2018
Skills
- Argus safety database management
- Quality assurance
- Client communication
- Team mentoring
- Problem solving
- Attention to detail
- Effective communication
- Team collaboration
- MedDRA expertise
- WHODD knowledge
- GLASS proficiency
- Microsoft Office suite
- Data interpretation accuracy
- Multitasking ability
Awards
- Star of the Month award, 04/2025
- Service and commitment award, 04/2024
Leadership Experience
- Delivered a presentation on narrative writing for unsolicited vaccine cases.
- Facilitated discussions and meetings to address and explain error trends.
- Provided mentorship and training to new team members.
Extracurricular Activities
- Played cricket and secured second place in a college-level competition.
- Participated in intercollegiate competitions, including poster making, logo design, and a chemistry-themed skit.
Hobbies and Interests
- Solving Sudoku puzzles
- Engaging in crafts
- Dancing
Languages
- English
- Hindi
- Marathi
References
Rishu Sharma, Team lead in Gilead, 7351331148
Timeline
Literature Quality Reviewer
TATA CONSULTANCY SERVICES- Project 1: Gilead Sciences Inc
04.2025 - Current
Literature reviewer
TATA CONSULTANCY SERVICES Project 1: Gilead Sciences Inc
10.2022 - 03.2025
Literature case processor
TATA CONSULTANCY SERVICES-Project 2: Alkem Laboratories Limited
03.2022 - 09.2022
Literature case processor
TATA CONSULTANCY SERVICES-Project 3: Cipla Limited
04.2021 - 02.2022
Junior Data Analyst
COGNIZANT TECHNOLOGY SOLUTION-Project: Sanofi Pasteur
06.2018 - 02.2021
BACHELOR OF PHARMACY (B. PHARM) - Chiplun, Maharashtra
Govindaro Nikam College of Pharmacy
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