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T.Vishwanath_CV

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T.Vishwanath_CV

  1. 1.     T.Vishwanath Cellular +91-9901650561 #007 LB Shastri Nagar, Vibhutipura Village, 7th Cross, HAL 2nd Stage Bangalore-560017 t.vishwanath@gmail.com Seeking assignment with a company with professional environment where my skills are valued and can benefit the organization. I am looking for a responsible job with an opportunity for professional challenges. Overview  Currently associated with Quintiles Technologies Pvt Ltd, Bangalore as Asst. Manager, Operations Team. My role specifically involves people management and client handling.  Working as Safety Trial Manager (designation with the client) since 3 years handling overall safety responsibilities for multiple clinical trial protocols and leading multiple teams.  Also, in my prior position of Sr. Operations specialist (Team Lead), I was the acting Manager and was responsible for managing the team as well as the client. I was the primary contact for all protocols that I handled.  Have been involved in project start up activities such as setting up SOW’s, work units and FTE calculations for various protocols.  Responsible for managing the overall safety for multiple clinical trial protocols and interacting with the entire project management leads on the client side (Clin. Operations, Site Management, Biostats, Data management) to ensure that the required deliverables are met within the specified time frame.  Have hands on experience on both Safety as well as Clinical Databases such as SEPTER, Argus, Medidata Rave, Inform and EXPeRT.  Have been successful in implementing several process improvements and have received several awards for the same. I believe in delighting the customer and have been praised by the client on several occasions for my pro-activeness and in managing my work and team in a systematic and organized fashion.  I am an effective communicator with good logical skills and ability to relate to people at any level of business and management.  Masters in Clinical Research and a bachelor’s degree in pharmacy with 4 years and 9 months of experience in safety reporting (2 years in Drug’s and 2.7 years in Medical Device’s) and a previous experience of 1 year in site management and co-ordination activities which makes it a total experience of 5.7 years in the clinical research arena.
  2. 2.       Employment History Employer/From – To Roles & Responsibilities Quintiles Employment History Quintiles Bangalore, India Device Safety reporting Apr-2013 – Present Asst. Manager Operations Team / Sr. Operations Specialist     SENR review     Source review (Review of Medical Records)     Case creation in Argus Database     Expedited reporting (Complaint reporting in the form of CTSENR’s)     Narrative writing (From Medical records and e-CRF pages)     Dossier preparation (CEC case dossiers submission to MR)     OTF review     E-Case management and Adjudication results review     QC of all activities performed for the project (which include QC of SENR, Source, OTF, Case entry, CTSENR, Narrative and Dossier, Adjudication results review)     To manage the CTSR meetings as applicable.     To update the safety and complaint plans as applicable.     To Participate in CRF and CSR review for safety related issues     DRU report review     Answered queries report review     Inactivation log review and approval     Work flow management (includes pulling reports for pending cases and taking appropriate action)     Completing all assigned trainings and SOP readings within specified timelines and updating the manager regarding the training completion status of the team members     To manage leaves within the team and ensure smooth management of daily work     To comply with People Soft Coding in a timely manner and ensure that all the team members are co-ordinate with the manager to ensure timely coding for all the team members     To actively participate and contribute in team meetings, process meetings, floor activities and new transitions.     To manage new transitions and contribute activity to the smooth transition and training of staff to handle new work efficiently     To communicate with the client by addressing to the correct person, by responding in a timely manner, escalating in right time, following up the issues and reporting the status to the Manager.     To facilitate the transition meetings with the Client, including requests for access.     To co ordinate the knowledge transfer process from Client to the team members.
  3. 3.           To ensure that there is appropriate documentation during the transition.     To ensure that the transition timelines are met as agreed with the Client.     To get signed off on all activities as agreed with the Client & implement sign off process for the team members as agreed with the LM.     To maintain highest quality standards and to ensure that the work quality of the team is per the expectations laid down Quintiles Bangalore Device Safety reporting Apr-2012 – Mar-2013 Operations Specialist     Checking central email folder daily for new source/emails from sites.     Queries in EDC for source.     Reviews and redacts source for complaints/unreported AEs.     Scans redacted source and stores on L drive under “source documents by site”.     Archives email to L drive under “source document email” folder.     Completes medical history and index procedure section of narrative.     Completes event section of narratives and confirms med history and index procedure sections are accurate.     Send CTSENRs to CCC (initial complaint) or CMC (for updates) for commercial/study complaints (could be identified from EDC, source, adjudication results).     Enter TW# in Argus once received from CCC.     Enters name in Argus as case owner of narrative.     Builds electronic dossier using Adobe Professional.     Submit narratives for medical review.     Review daily SENR report.     Attends project team meetings as necessary. Quintiles Bangalore Device Safety reporting Aug-2011 – Mar-2012 Associate Operations Specialist     Checking central email folder daily for new source/emails from sites.     Queries in EDC for source.     Reviews and redacts source for complaints/unreported AEs.     Scans redacted source and stores on L drive under “source documents by site”.     Archives email to L drive under “source document email” folder.     Completes medical history and index procedure section of narrative.     Completes event section of narratives and confirms med history and index procedure sections are accurate.     Send CTSENRs to CCC (initial complaint) or CMC (for updates) for commercial/study complaints (could be identified from EDC, source, adjudication results).     Enter TW# in Argus once received from CCC.     Enters name in Argus as case owner of narrative.     Builds electronic dossier using Adobe Professional.     Submit narratives for medical review.     Review daily SENR report.
  4. 4.           Attends project team meetings as necessary. Quintiles Bangalore Drug Safety reporting Apr-2010 – Jul-2011 Drug safety Associate -2     Triage of incoming cases to determine seriousness for prioritization of daily workflow.     Confirmation of previously entered data and completion of data entry, including writing adverse event case narrative; assess expectedness of adverse events and code approval numbers.     Complete quality review of own or peer DSA case executing literature searches to identify adverse events for inclusion in the worldwide safety database.     Follow procedures for supporting activities, such as requesting deletions, addition of new codelist terms, preparing deviation memos, etc.     Understand safety implications regarding contracts with client's marketing partners.     Led, managed and processed adverse event/serious adverse (AE/SAE) case reports from multiple clinical trials and post-marketing studies for submission to worldwide regulatory authorities according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements in both the Pharma and Consumer segments.     Good at handling the projects independently and as a team.     Good understanding of the quality & confidentiality of patient data and process involved in processing the data to make it presentable as per regulatory requirements.     Worked for the company at the time of crisis. Quintiles Bangalore Drug Safety reporting Sep-2009 – Mar-2010 Drug safety Associate -1     A post marketing surveillance involving meticulous processing of patient reports received from the client’s trial sites and marketed by abiding the standard operating procedures (SOP).     Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory to avoid reporting of the incorrect data and by maintaining the confidentiality of the patient details.     Involves important decision making for entering the case in to the data base, processing the patient data, assessing the seriousness, monitoring the adverse events, coding the events with the help of MEDRA, labeling the events according to the Company Core Data Sheet.     Trained on Literature surveys, reviewing, assessing and decision making for reportability by looking for positive attribution in the literature article. Institute of Clinical Research (India) (consultants) for Kumar Organics products private Ltd. Study management and site Co-ordination activities
  5. 5.       SEP-2008 to AUG2009  Developing and reviewing Protocol, CRF's, Informed Consent Forms, Subject Information Sheets and Trial related check lists.     Writing SOP's and Reports     Questionnaire development and validation     Subject recruitment     Investigator and staff training     Reporting and coordinating Academia  Masters in Clinical Research from Indian Institute of Clinical Research, Cranfield University (UK) in 2009. Secured 80%. Topper for Cranfield University for the year 2009.  P.G Diploma in Clinical Research Management from Indian Institute of Clinical Research, Bangalore in 2009. Secured 85%.  Bachelors in Pharmacy from Al-Ameen College of Pharmacy, Bangalore in 2006. Secured 73%. Systems Experience/IT Skills  Well versed with MS-Office: (Word, Excel, PowerPoint) and Outlook  Highly proficient Internet Browsing skill. Activities and Honors  Have received academic excellence award (Gold Medalist) in M.Sc at ICRI  Certification - ICRI in collaboration with FDASmart Inc, USA. at ICRI Bangalore, Karnataka, 2008  Accomplished black belt certification in karate and have won many national and international medals. Volunteered for  Association of Pharmaceutical teachers of India, Bangalore Karnataka (2006): Was member of a team responsible for ensuring coordination between different departments for organizing the event.  National Service Scheme (NSS), Bangalore, Karnataka (2003)  Took the responsibility and organized blood donation camp (2003) Personal details  Date of Birth: 06th Sep 1984  Languages Known: English, Hindi, Telugu and Kannada References Will be provided on request
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