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
Microsoft Office Suite Spreadsheet proficiency Presentation skills Data analysis
ARISg safety database agXchange platform Argus safety database
Drug Regulatory Affairs (DRA) certification
Dedicated
Adaptability
Effective communication
Collaborative team member
Management skills
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