Summary
Overview
Work History
Education
Skills
Certifications And Systems
Software
Certification
Timeline
Generic

Milind Lade

Pharmacovigilance
Thane

Summary

Results-driven pharmacovigilance professional with over a decade of experience in global drug safety operations. Expertise in ICSR processing, team leadership, and regulatory compliance. Currently leads a 15-member clinical safety team, managing quality deliverables, audits, CAPA processes, and stakeholder communication. Skilled in high-volume, client-facing environments with global pharma and CRO partners. Specialized in Veeva Vault Safety, including implementation, UAT/SMOKE testing, configuration support, and user issue resolution. Collaborates across functional teams, supports safety database migrations, and ensures compliance with global regulatory standards. Strong communicator and project liaison with proven experience in client-facing delivery and system optimization. Aspires to transition into a manager role to drive safety operations focusing on compliance, quality, and team development. Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Combines strategic thinking with hands-on experience to deliver impactful solutions and enhance organizational performance.

Overview

10
10
years of professional experience
4027
4027
years of post-secondary education
3
3
Certifications

Work History

Team Lead – Pharmacovigilance Operations

Cognizant Technology Solutions
Navi Mumabi
07.2022 - Current
  • Lead a 15-member team handling global clinical trial safety cases and regulatory compliance.
  • Responsible for operational oversight, production scheduling, and quality monitoring.
  • Conduct internal QC, prepare TAT/billing reports, and lead monthly operations reviews.
  • Act as project lead for UAT/SMOKE testing in Veeva Vault; support issue resolution across global PV operations.
  • Own team performance, training documentation, and audit readiness planning.
  • Led UAT/SMOKE testing efforts during system upgrades, ensuring release validation and stakeholder sign-off.
  • Directed the safety case lifecycle through VVS, ensuring audit readiness and document completeness
  • Coordinated internal teams and collaborated with client-side IT teams for troubleshooting, configuration, and training.
  • Managed onboarding/offboarding, led FMEA and CAPA implementation for compliance tracking.
  • Serve as POC for FMEA, CAPA, and deviation management initiatives.
  • Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
  • Assisted in recruitment to build team of top performers.

Data Analyst – Pharmacovigilance

Cognizant Technology Solutions
Navi Mumbai
04.2020 - 06.2022
  • Processed 4000+ ICSR cases in ARISg and Veeva Vault Safety databases.
  • Extracted and coded data from Medidata Rave (EDC) and performed QC reviews.
  • Supported case reconciliation corrections, narrative development, and query management.

Pharmacovigilance Officer

Covance Clinical Development Pvt. Ltd.
Navi Mumbai
10.2018 - 03.2020
  • Managed over 2000+ SAE reports and served as India-based POC for multiple sponsor studies.
  • Reviewed and triaged 2000+ safety reports, responded to sponsor queries, and supported audits.
  • Provided compliance tracking and training support to global safety associates.

Drug Safety Associate

Tata Consultancy Services
Thane
03.2015 - 09.2018
  • Managed spontaneous and post-marketing 5000+ AE reporting using Argus and Camel.
  • Supported regulatory case submissions, drafted narratives, and monitored quality KPIs.
  • Served as backup lead for mailbox management and case distribution.
  • Assisted in the development and implementation of training materials, contributing to the ongoing education of fellow Drug Safety Associates.
  • Improved patient safety by accurately reviewing and processing adverse event reports.
  • Streamlined case management processes, ensuring timely submission of quality reports to regulatory authorities.

Education

Master of Pharmacy -

Shivaji University
Maharashtra
07-2014

Bachelor of Pharmacy -

Shivaji University
Mahrashtra
07-2012

Skills

Certifications And Systems

  • Safety Databases: Veeva Vault, ARISg, Argus, Camel
  • Tools: Medidata Rave, IBM Merge
  • Quality: CAPA, RCA, FMEA, GVP Modules I–VIII
  • Soft Skills: Team Mentoring, Cross-functional Collaboration, Client Engagement

Software

ARGUS

ARISg

Veeva vault safety

Medidata

Certification

Gen AI for beginners

Timeline

Team Lead – Pharmacovigilance Operations

Cognizant Technology Solutions
07.2022 - Current

Data Analyst – Pharmacovigilance

Cognizant Technology Solutions
04.2020 - 06.2022

Pharmacovigilance Officer

Covance Clinical Development Pvt. Ltd.
10.2018 - 03.2020

Drug Safety Associate

Tata Consultancy Services
03.2015 - 09.2018

Master of Pharmacy -

Shivaji University

Bachelor of Pharmacy -

Shivaji University

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Milind LadePharmacovigilance