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.
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.
 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.
 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.
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