Vinay Urs

Experience

• 

  Bangalore Diabetes Hospital

  Jul 2008 - Jul 2010

  Senior Clinical Research Coordinator

  Has lead a group of clinical research coordinators and participated in more than 10 National and International, Phase- IIa, II/III, III, IV & PMS Clinical Trials in Type 1 & Type 2 Diabetes mellitus and other Endocrine and Metabolic disorders.Key Responsibilities : • Pre trial activities, feasibility and budgeting, planning and executing the studies, communicating with Sponsor’s & CRO’s, QA and QC activities, managing communication with Ethics Committee, arranging Ethics Committee meetings and other correspondences, coordinating the Clinical trials.Research Coordinator Activities:• Participation in 5 Investigator’s Meeting in India and Abroad, site initiation, informed consent documentation, IVRS and IWRS handling, subject care, source and other documentation, safety reporting, drug accountability and dispensing, entering CRF, e-CRF and query resolution, site close out and archiving and have faced CRO and Sponsor Audits for Diabetes mellitus trials. Show less

• 

  IQVIA

  Jul 2010 - Feb 2014

  • Handling team related activities like daily work allocation, provide training and mentoring for project team members and department staff; assist management with allocating resources to project.• Key member of ARGUS safety database core training group and has under gone train the trainers (TTT) training for the same in on shore office (head quarters) in United States.• Certified quality reviewer and plays a role of mentor to new joiners and junior associates.• Plays the role of SME and member of core group for PhV agreement drugs from partner companies, helps reconciliation to follow-up of cases to mirror both the databases of Sponsor as well as Partner Company.• Performing trend analysis of PhV agreement drugs to maintain compliance and providing root cause analysis (RCA) for the late cases in compliance reports.• Providing consistent and frequent feedback to project team members on quality, efficiency and progression.• Conducting quality review team meetings, preparing and contributing to meeting materials such as minutes of meetings. Show less • Receive, triage, process and quality review safety data like Serious and Non-serious Adverse Events and Adverse Drug Reactions from various sources on time, within budget and quality standards.• Perform edit checks/inconsistency checks to determine whether PT (preferred term), Regulatory labeling of events and reporters are captured correctly and reported appropriately.• Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Preparation of material for submission of secondary review.• Process LifeCycle safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.• Build a positive, collaborative team environment with Lifecycle safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff. Show less

  • Drug Safety Operations Scientist

    Apr 2013 - Feb 2014

  • Senior Drug Safety Associate

    Jul 2010 - Apr 2013
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  Novartis

  Feb 2014 - Aug 2020

  • Lead and monitor the team performance and driving the safety case processing activities to ensure compliance and quality including the ESP’s.• Ensure workload monitoring and appropriate resource allocation.• Interact with ESP’s to review their performance and identify areas of development for capability building.• Represent case management in functional and operational forums.• Deputize Head Safety case processing in various forums and activities as required. • Supervise Case Management staff (internal and external) in accordance with organization’s policies and values and behaviors. Responsibilities include planning and directing work; professional development guidance; resolving problems and absence management.• Ensure associates are cross-trained on responsibilities as applicable; monitor and develop training plans; identify training and development needs of staff in collaboration with Training team and Management.• Lead and encourage associates in continuous improvement of department work processes, and procedures; also act as SME and Mentor for team members.• Representing Case Management team as Project business lead for special projects like Argus database update and process optimization, PV reports generation and automation.• Act as a subject matter expert during audits and inspections; lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.• Acting as a Project POC by preparing project plan and summary reports for the special projects planned to clear bulk deliverables.• SME and member of core group in driving the process improvements from Case Management.• Preparation of relevant processing manuals like study guidance document, product guidance document and contribute to work instructions, SOP’s and manuals as per requirement. Show less

  • Manager, Safety Case Processing

    May 2019 - Aug 2020

  • Senior Pharmacovigilance Scientist

    Apr 2017 - Apr 2019

  • Pharmacovigilance Scientist

    Feb 2014 - Mar 2017
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  Eli Lilly and Company

  Sept 2020 - now

  • Manager (Global Lead)

    Mar 2023 - now

  • Senior Associate Manager

    Sept 2020 - Feb 2023