OVERVIEW
FOCUS AREAS
More than 14 years of experience in the life sciences industry.
Safety Systems Evaluation & Implementation
Safety System Configurations
Case Processing Automation & Data Intake Solutions
Regulatory Compliance & E2B R2/R3 Implementations
EDI Gateway Setup
As a Managing Consultant, Unmesh Chimalwar advises leading pharmaceutical companies on pharmacovigilance system strategy, regulatory compliance, and technology transformation. With over 14 years of experience in the life sciences domain, he has developed deep expertise in PV system implementations, upgrades & integrations.
Unmesh began his PV consulting career in 2011 at Foresight Group International AG, delivering strategic technology solutions to leading pharmaceutical companies. Unmesh is a recognized subject matter expert in E2B R2/R3 regulations for drugs, devices, and vaccines. He has successfully led more than 20 global projects, including top tier pharmaceutical companies.
Prior to joining ELIQUENT, Unmesh was an Engagement Manager at IQVIA where he was known for his leadership in complex system transformations and played a key role in developing business and technical solutions, conducting client workshops, and delivering user trainings. His ability to translate regulatory and business requirements into scalable technology solutions has made him a trusted advisor in the pharmacovigilance space.
-
EDUCATION:
Master of Computer Applications, Bharati Vidyapeeth’s Institute of Computer Applications and Management
2010-2012 -
Domain Expertise
- Safety Systems Evaluation & Implementation
- Safety System Configurations
- Case Processing Automation & Data Intake Solutions
- Regulatory Compliance & E2B R2/R3 Implementations
- EDI Gateway Setup
Representative Projects
- PV System Implementation and upgrade for several top-tier pharmaceutical companies
- PV System integration with other source systems at leading pharmaceutical companies
- PV System Configuration including Code Lists, Business Configuration and System Configuration
- Case Intake interfaces for E2B R3+ files, Excel, and ASCII files received from Regulatory Authorities
- Case Processing Automations
- Authoring of regulatory, business, and functional requirements along with user and functional test scenarios
- PV System customizations for regulatory submissions including FDA R3, LATAM, EMA Audits, MIR, FDA Combo Products/Vaccines, eMDR implementation, MFDS & NMPA R3
- Established E2B exchange using gateway with Health Authorities.