Umesh Kolte
Team Leader, Pharmacovigilance
- Role
- Team Leader - Pharmacovigilance at Tata Consultancy Services
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Umesh Kolte
Master of Science in Pharmaceutical Medicine with extensive knowledge of Clinical trials, Pharmacovigilance and Regulatory Guidelines. More than 5 year experience in Pharmacovigilance including 4 year experience of leading teams of spontaneous and clinical trial ICSR processing. Having excellent interpersonal and communications skills. Proven abilities in team management, process enhancement, training & team development.Specialties: Computer System Validation, Business Analysis for Regulatory, Clinical and Drug Safety Computer system applications.Domain Consultant for Pharmacovigilance, Clinical Research
Experience
Team Leader - Pharmacovigilance
Jun 2010 — Present
I have experience of working on multiple Pharmacovigilance projects as a Team Leader. As a team Leader I am responsible for day to day activities of Pharmacovigilance team. Provide technical expertise and resolve project related queries. Assign adverse event reports to Case Handlers in the team and ensure completion of ICSR as per agreed time. Ensure compliance with global & local procedural documents. Identify and if require undertake necessary process related training. Ensure adequate resource of the project throughout it\'s lifecycle.
Education
Maharashtra University of Health Sciences
Master of Science, Pharmaceutical Medicine
2006 — 2008
Axelos
ITIL V3 Foundation, IT Service Management
2014
TCS
Six Sigma Green Belt
Maharashtra University of Health Sciences
BAMS, Ayurved Medicine
1998 — 2003
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