Dr. Kiran Kandula

Experience

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  Surya Dental hospital, Hyderabad

  Nov 2004 - Oct 2006

  Dental surgeon
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  Dr. Yathish Dental clinic

  Oct 2006 - Nov 2007

  Dental surgeon
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  Nizams Institute of medical Sciences

  Jan 2008 - Jan 2009

  Clinical Research Coordinator

  Handled 6 various clinical research projects.Having experience in handling trials in Immunology and Rheumatoid Arthritis, SLE, Osteoarthritis, Polymyositis.Responsibilities:Corresponding for all documentation work required for site selection, Site initiation with the monitors and Submission of Documents to Ethics Committee for Approval, Identifying subjects meeting the eligibility criteria, Taking Informed Consent, Randomization using IVRS, Dispensing Study Medication, Writing source document, regular follow up patient and capturing the AE and SAE's and reporting them to appropriate authorities within specified timelines,Electronic Data Capturing, Call Monitoring, Resolving queries,Drug accountability and also taking part in protocol discussion during the investigators meetings and site initiations. Medical data review and identifying the data discrepancy.Reporting of AE and SAE. Show less

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  Tata Consultancy Services

  Jan 2009 - Oct 2010

  Patient Safety Specialist

  Job profile: Handling the Spontaneous, Literature and Clinical trial Adverse event reports from all over the world.Receive information on adverse events, perform duplicate search and initiate received drug safety report in database.Triaging the case to prioritize the case for Expedited reporting. Ensure accurate complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality.Coding of medical history and adverse event by using the MedDRA.Identify missing information which is important for the case and raising the follow-up requests when required.Clinical trail case handling I am using different tools of WBDC web based data capture like MediData Rave, InForm, Cool. Code breaking information using Grand.Quality review of the processed cases for the completeness and accuracy.Preparation of the narratives summarizing the essentials of the case.Assist in administrative activities and training the personnel when required.As a Mentor:Expertise in handling the expeditable cases with good understanding on regulatory requirements.Provide support in the case handling process to the team members, assigned mentees.Respond to queries related on the case handling processTo assist the mentees in the sign-off process.To identify areas that may require further training and communicating with the trainers regarding the same. Show less

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  Parexel

  Oct 2010 - Oct 2023

  Line and General Management:  Managed Mid and Large Teams, Highest team being 450 FTE+. which include ICSR, Aggregate, Medical function related activities. Responsible for project or process for a client depending on the team size, complexity of the processes or span of controlClient Liaison/Service: Build and maintain collaborative client relationships, to cultivate efficient, productive, and professional working relationships that promote satisfaction and confidence. Implement quantitative measures of performance (key performance indicators provided by the client or developed internally) into feedback, metrics, and continuous improvement activities to optimize performance in a data-driven manner. In the proposal generation process, provide strategic and project planning intelligence to safety services management for standalone through end-to-end safety services Provide an assessment of scope of services for clients with respect to safety services tasks, including a description of the services to be performed and estimated hours for each task. Liaise with the proposal team and/or client to ensure that the proposal covers all services required.Project Management: As applicable, manage individual, partner, stakeholder, and customer relationships and their performance; manage partnership operations, relationships, and personnel. Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks.  Continuously monitor overall project performance  Keep client and team informed of project status. Provide project updates to safety services management and assess forecasting and resourcing. Propose creative solutions for shifting timelines and staffing requirements to safety services management. Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects. Ensure appropriate changes in scope are escalated. Show less • Assign Drug Safety staff to projects as per the project requirements, delegate work to Drug Safety staff according to allocated budget/hours • Ensure that the work provided by the Drug Safety staff is in accordance with the hourly budget provided.• Assist in interviews for recruitment of new personnel and in termination of employment as necessary. • Perform annual appraisals of Drug Safety staff, and provide recommendations for promotions, career development, and identify and resolve employee issues potentially impacting project performance and team spirit • Prepare for and respond to internal/external audits • Work with Medical Advisors/Medical Directors/Drug Safety Physicians as needed • Assist Management with preparation of project resourcing estimates, leading client meetings and other management activities as needed. • Prepare for and respond to internal/external audits Show less • Assign Drug Safety staff to projects as per the project requirements, delegate work to Drug Safety staff according to allocated budget/hours • Ensure that the work provided by the Drug Safety staff is in accordance with the hourly budget provided.• Assist in interviews for recruitment of new personnel and in termination of employment as necessary. • Perform annual appraisals of Drug Safety staff, and provide recommendations for promotions, career development, and identify and resolve employee issues potentially impacting project performance and team spirit • Prepare for and respond to internal/external audits • Work with Medical Advisors/Medical Directors/Drug Safety Physicians as needed • Assist Management with preparation of project resourcing estimates, leading client meetings and other management activities as needed. • Prepare for and respond to internal/external audits Show less

  • Director, Pharmacovigilance

    Apr 2023 - Oct 2023

  • Associate Director

    Apr 2021 - Apr 2023

  • Senior Manager

    Nov 2018 - Mar 2021

  • Team Manager

    Nov 2015 - Nov 2018

  • Associate Manager

    May 2013 - Nov 2015

  • Drug Safety Specialist

    Oct 2010 - May 2013
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  ProPharma

  Oct 2023 - now

  Senior Director, Head Pharmacovigilance Operations (India)