Dr. Jalaja Ganganna has over 15 years of experience in clinical research and drug safety. She currently works as a Senior Drug Safety Associate at Quintiles, Bangalore, where she is responsible for adverse event reporting and case processing. Previously she worked as a Senior Clinical Research Coordinator at ChanRe Rheumatology and Immunology Center, where she managed over 25 clinical trials and ensured regulatory compliance. She has participated in numerous investigator meetings and trials remain qualified through continuing education.

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Dr. JALAJA GANGANNA, B.A.M.S.,
#57, 7th
Cross, 3rd
Main Road, 6th
Block,
2nd
Stage, Nagarbhavi, Bangalore-560072.
Email: jalaja.pragnya@gmail.com
Mobile No: +91 9632266665
OBJECTIVE:
Seeking a key position in a leading pharmaceutical/clinical research industry which offers
professional growth to utilize my skills and abilities which are innovative and flexible.
EDUCATIONAL QUALIFICATION:
Degree University Year of Completion
P.G Diploma in Clinical
research and Regulatory Affairs
Manipal University, Bangalore Year 2009
Bachelor Of Ayurveda
Medicine and Surgery
Indian Institute Of Ayurvedic
Medicine and Research, Bangalore
Year 2003
WORK EXPERIENCE:
Organization Job Title Period
Quintiles, Pvt Ltd, Bangalore Senior drug Safety
Associate
02-04-2014 to Till date
ChanRe Rheumatology and Immunology
Center & Research, Bangalore
Senior Clinical research
coordinator
18-06-2012 to 10-02-2014
ChanRe Rheumatology and Immunology
Center & Research, Bangalore
Senior Clinical research
coordinator
12-02-2010 to 18-06-2011
PROFESSIONAL SUMMARY:
1. Quintiles, Pvt Ltd, Bangalore
 Responsible for the receipt and data entry of adverse event reports following
Company Standard Operating Procedures, internal business practices and regulatory
guidance documents to ensure compliance with worldwide safety regulations,
corporate policies.
 Completion Of case processing (Case data entry, labelling, approval numbers, manual
coding, narrative writing) and Quality review
 Preparation of deviation memo as necessary
 Other Case processing related activities (e.g. review of consistency checks,
reconciliation etc).

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 To adhere Standard Operating Procedures, Working instructions and Guidelines,
MedDRA coding dictionary and MedDRA points to consider.
 Review and make suggestions for system and procedure enhancements. Project Work,
Audits. Inspections and other Ad-hoc Requirements
 Participations in Customer projects, preparation for audits. inspections and Business
continuity plan
 Continuous development of personal skills. Whether task or competency related
activities including technical training & e-learning, Workplace shadowing, mentoring
others, project involvement and Soft skill development activities.
2. ChanRe Rheumatology and Immunology Center & Research, Bangalore.
 Responsible for the average of 25-30 clinical trials.
 Involved in preparing the Site SOP.
 Developing and negotiating study budgets and facilitating the contract review process.
 Communicating with the IEC as appropriate.
 Involved in pre-screening, screening, recruiting and enrolling patients.
 Proper handling & processing of collected samples and shipping.
 Involved in scheduling and conducting the follow up visits.
 Maintaining and ensuring quality of case report forms in paper formats and electronic
case report forms such as OCRDC, RAVE, PDS, INFORM.
 Maintaining the regulatory and study files for each research project.
 Assuring proper handling of the investigational product.
 Reporting adverse events to the IEC and sponsor, as appropriate.
 Meeting with sponsor representatives to discuss planned and ongoing studies during
the monitoring visits.
 Participating in quality assurance activities of the sponsor.
 Overseeing study closure.
Few Clinical Trials Participated as Coordinator:
 Protocol Title – A Multicenter, Randomized, and Double – Blind, Placebo controlled
trials of study drug, a Fully Human Anti-TNF  Monoclonal Antibody, Administered
Subcutaneously, in Methotrexate-naïve subjects with Active Rheumatoid Arthritis.
 Protocol Title – A Phase III, Multi-center, randomized double blind, controlled study
of the long term analgesic efficacy and safety of study drug alone or in combination
with non-steroidal anti-inflammatory drugs (NSAIDs) versus NSAIDs alone in patients
with osteoarthritis of the knee or hip.

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 Protocol Title – A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Trial
of the Safety of study drug for the Prophylaxis of Gout Flares in Patients on Urate
Lowering Therapy.
 Protocol Title – A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of
study drug in Patients with Active Rheumatoid Arthritis on Concomitant DMARD
Therapy.
 A phase 3, Randomized, double-blind, Active Comparator study of the Efficacy and
Safety of R-TPR-015(1422015) in Patients with Active Rheumatoid Arthritis on the
stable dose of Methotrexate.
 A phase 3, randomized ,double-blind, placebo-controlled, multicenter study of the
efficacy and safety of four 12 week treatment cycles(48 weeks total) of epratuzumab in
systemic lupus erythematosus subjects with moderate to severe disease(EMBODY 2).
 A phase 2b, dose-ranging study to evaluate the efficacy and safety of Sifalimumab in
adults with systemic lupus erythematous.
Investigator Meetings attended:
 Participated in the Investigators meeting held at Bangalore, Dec 2010.
 Participated in the Co-ordinator’s meeting held at Mumbai on 10th
Feb 2013.
 Participated in the Investigator’s meeting held at Delhi on 22nd
-24th
Aug 2013
Audits
 Sponsor audit –No findings.
OTHER PROFESSIONAL EXPERIENCE:
Ten years experience as a consulting physician in various medical centers of Bangalore.
 Sudhanwa Health care & Research center, R.R. Nagar-Aug 2003 to Nov 2004
 Himalaya Drug Company, Outlet at Cox town & Basaveshwaranagar-Nov 2004 to June
2005
 Panacea Hospital, Basaveshwaranagar-April 2006 to Nov 2006
 Arya Vaidya Sala, Kottakal, R.R. Nagar-Nov 2006 to Jan 2010
 Jeevani Ayurveda Center, Nagarbhavi-April 2004 to April 2014
PERSONAL DETAILS:
Gender Female
Nationality Indian
Marital Status Married
Languages Known English, Hindi, Kannada and Tamil
Date of Birth 17th
May 1979