Nilesh Dali
Team Leader
Thane West
Summary
Detail-oriented individual with exceptional administrative skills, dedicated to delivering high-quality work and exceeding organizational goals.
Overview
12
12
years of professional experience
Work History
Team Leader
Cognizant Technology Solutions
11.2021 - Current
- Handling team of 15 pharmacovigilance specialists, facilitating case management, daily operations, and regulatory reporting activities, upholding compliance with global pharmacovigilance regulations.
- Mentored and guided team members, encouraging a synergistic work environment and advancing team performance.
- Analyzed KPIs and SLAs to pinpoint operational bottlenecks, supporting prompt corrective actions to sustain quality standards.
- Orchestrated communication with cross-functional teams (Translation and Data entry) to assure thorough reporting and processing of adverse events (AEs).
- Function as key communicator for internal stakeholders and health authorities, maintaining clarity and timeliness in adverse event reporting discussions.
- Presented ongoing updates to senior management concerning pharmacovigilance metrics, case processing status, and risk management outcomes.
- Managed thorough audits (external & internal), identified systemic inefficiencies, and advocated for corrective strategies, resulting in elevated audit performance and strict compliance with regulatory requirements.
- Coordinated efforts for regulatory inspections (FDA, EMA) by confirming team preparedness and adherence to documentation standards, culminating in successful inspection outcomes.
- Produced training documentation and executed ongoing sessions, boosting team skills and alignment with pharmacovigilance standards.
- Performed structured interviews to analyze candidates’ technical skills, cultural alignment, and overall potential, guaranteeing selection of exceptional team members.
- Supervised data entry and analysis of adverse events in safety databases (e.g., Argus) maintaining high-quality, accurate, and timely data reporting.
Team Leader & Trainer
Tata Consultancy Services (TCS)
10.2013 - 10.2021
- Worked as Team Leader from Sep 2020 to Oct 2021
- Oversee team operations and performance, ensuring consistent achievement of objectives
- Managed workflow activities with case assignments to enhance operational efficiency. Oversaw mailbox management to ensure timely responses and organization of communications.
- Conducting monthly performance evaluations with team members
- Conducting daily huddles to communicate updates
- Guiding team members to ensure timely and effective resolution of all client queries, enhancing customer satisfaction
- Executing KPI and billing tasks
- Address client queries and manage voice calls with clients.
- Managing onboarding and offboarding of associates
- Facilitate query resolution for team members daily while offering subject matter expertise when needed
- Certify as project-specific trainer in 2017
- Facilitate training and mentorship for data entry personnel as needed.
- Developing monthly training compliance dashboard
- To execute Individual Case Safety Report (ICSR)
- Route processed ICSRs to subsequent workflow.
- Quality review of Solicited/Post marketing, Spontaneous, Literature and Clinical Trial cases adhering to work instructions.
- Produce comprehensive reports and conduct detailed analysis of data
- Facilitate quality awareness sessions and engage in quality-related activities.
- Query resolution
- Coaching of new team member.
Education
Bachelor of Pharmacy - undefined
Indira Institute of Pharmacy College
Sadavali, Devrukh01.2012
Higher Secondary School Certificate - undefined
Kolhapur Board
01.2008
Secondary School Certificate - undefined
Kolhapur Board
01.2006
Skills
Proficient in office applications
Interests
Playing cricket and Carrom
Accomplishments
- Appreciation received from Client for resolving project quality issue and made project in green as per client SLA.
EXTRA CURRICULAR ACTIVITIES/ACHIEVEMENTS
Participated in corporate level cricket tournaments and have won prizes in multiple categories. Participated in inter TCS carrom tournaments.
OTHER ACTIVITIES
- Faced internal and client audit multiple times in current and previous organization.
- Preparing CAPA for TAT miss cases and Quality errors cases and sending to the client.
DECLARATION
I hereby confirm that the information in this RESUME is true and correct to the best of my Knowledge and I look towards receiving a favourable reply from your esteemed organization.
Date:
Nilesh Nandkumar Dali
Timeline
Team Leader
Cognizant Technology Solutions
11.2021 - Current
Team Leader & Trainer
Tata Consultancy Services (TCS)
10.2013 - 10.2021
Bachelor of Pharmacy - undefined
Indira Institute of Pharmacy College
Higher Secondary School Certificate - undefined
Kolhapur Board
Secondary School Certificate - undefined
Kolhapur Board