Elango Umarani July 20, 2016
Elango Umarani. Bsc (Micro biology).
Blk 30, #015-87,
Kelantan road,
Singapore – 200030.
Phone: (065)-84551656
Email: umasingapore2010@gmail.com
SUMMARY:
Seven years in Clinical research and currently three years and two months in
Pharmacovigilance experience in Immunology, Infectious Diseases, Oncology and
Cardio-Metabolic Diseases. Achieved Bachelor degree in Micro Biology at
Bharathidasan University in India.
EDUCATIONAL QUALIFICATION:
 Graduate, B.Sc Micro Biology, Apr 2006
Bharathidasan University, Trichy, TamilNadu, INDIA
 High School, Higher Secondary & Biology, May 2003
St Justin's Girls Hr Sec School, Sivagangai, TamilNadu, INDIA
 High School - Same Institution (1), High School, May 2001
St Justin's Hr Sec School, Sivagangai, TamilNadu, INDIA
PROTOCOL THERAPEUTIC EXPERIENCE
Therapeutic
Area
Indication
Group
Primary
Indication
Role Number
of
Studies
Duration Phase Subject
Population
Cardio-
Metabolic
Diseases
Arrhythmia Atrial Arrhythmia Drug
Safety
Associate
2 2 yrs, 7
mos
IV
Cardio-
Metabolic
Diseases
Arrhythmia Atrial Arrhythmia Drug
Safety
Associate
1 2 yrs, 7
mos
IV Cardiovascular
Subjects
Cardio-
Metabolic
Diseases
Peripheral
Vascular
Disease
Venous
Thromboembolism
Drug
Safety
Associate
1 2 yrs, 7
mos
IV
Immunology Autoimmune
Disorders
Psoriasis Drug
Safety
Associate
1 2 yrs, 11
mos
III Psoriasis
Subjects

Elango Umarani July 20, 2016
Immunology Autoimmune
Disorders
Rheumatoid
Arthritis
Drug
Safety
Associate
1 2 yrs, 10
mos
III Rheumatic
Subjects
Infectious
Diseases
Antivirals Hepatitis B Drug
Safety
Associate
1 2 yrs II
Infectious
Diseases
Antivirals Hepatitis B Drug
Safety
Associate
2 2 yrs, 10
mos
III
Oncology Solid
Tumors
Breast Drug
Safety
Associate
1 2yrs, 2
mos
III Female only,
Oncology
subjects
Oncology Solid
Tumors
NSCLC Drug
Safety
Associate
1 2 yrs, 2
mos
III Oncology
subjects
CURRENT JOB
Company PRA Health Sciences
Job Title Drug Safety Associate 1
Company Location 21 Biopolis Road #02-06 Nucleos North Tower,Singapore138567
Duration May 2013 - Present 3 yrs, 2 months
Scope/Responsibilities
• Supports the generation of Aggregated Safety Reports (e.g. EU Annual Safety
Report, IND
• Annual Report, Periodic Safety Update Reports, and other cumulative safety
reports) through data retrieval and other assigned tasks.
• Generates data listing from the safety database and assumes responsibility for
accuracy of the data.
• If SAEs are reported from blinded trials, the DSA assures maintenance of blinded
treatment code, specifically when involved in the unblinding for regulatory
reporting purposes.
• Submits Expeditable safety reports to Regulatory Authorities, IRB/ECs, and
investigational sites in accordance with relevant legislation and the project-
specific contractual agreement, including electronic submission to the
EudraVigilance database (EV Web application or Gateway).
• Assesses Reportability of ICSRs based on the project-specific Safety Reporting
Assessment sheet
• Performs consistent coding of diseases, adverse events, and medications
according to the project-specific coding conventions in the Safety Database
Ensures personal career goals are set each year and progress is monitored
for completion
This includes:
1. Tracking of Received ICSR
2. Entry of ICSR into PRA or Client safety database

Elango Umarani July 20, 2016
3. Query Management Receives (by fax, e-mail or phone call) and processes
individual case safety reports (ICSR; e.g.serious adverse events, adverse events of special
interest, and suspected ADRs) from clinical trial, spontaneous and from published reports
(e.g. from the literature, received from Regulatory Authorities).
4. Supports interim data analysis for DMC reviews
5. Receives inquires via phone, fax or email from consumers or healthcare
professionals in support of marketed products ; triages the inquiry as a
request for medical information, product quality compliant and / or adverse
event and processes received information in accordance with project specific
instructions.
6. Properly documents all internal and external contacts and communications
(e.g. with reporters of cases, sites, or clients whether verbal or written)
7. Consistently meets or exceeds SRM objectives set annually Generates
concise, accurate and well-written case narrative
System Experience (Drug Safety Associate 1, PRA Health Sciences)
Type Safety
System ARGUS
Level of Expertise 3-Expert
Type Safety
System Oracle AERS
Level of Expertise 1-Basic
Type EDC
System Medidata RAVE
Level of Expertise 1-Basic
EMPLOYMENT HISTORY#1
Company ICON plc clinical research pte ltd.
Job Title Medical Administrator
Company Location ICON Clinical Research Pte Ltd, SINGAPORE
Duration Jun 2010 -Apr 2013 2 yrs, 10 months
Scope/Responsibilities
• Maintain data entry for Serious Adverse Event and miscellaneous tracking logs
for all current studies
• Maintain office supplies and equipment
• Handle mailing activities for Medical Affairs and Drug Safety (Ship, FedEx, Mail
room, etc.)
• Distribute all subject specific material to appropriate ICON staff

Elango Umarani July 20, 2016
• Assist with organization and planning of meetings, including preparation and
distribution of presentations, agendas, and meeting minutes, as requested.
• File all Medical Affairs and Drug Safety documents within allotted timeframes
• Distribute Exception Approvals, hospital records, and miscellaneous
documentation to Sponsor contacts in accordance with Standard Operating
Procedures and SSPs
• Distribute Serious Adverse Event Reports to Sponsors, sites, and applicable ICON
personnel in accordance with Standard Operating Procedures and SSPs
• Provide administrative support for Medical Affairs and Drug Safety
• Daily entry into, and maintenance of, appropriate tracking systems(e.g. SAE
tracking system)
• Other administrative tasks as identified and requested by management
• Answer SAE Hot Line, and other departmental phone lines as necessary;
document contacts and submit to appropriate personnel
EMPLOYMENT HISTORY#2
Company Cutech Solutions & Services Pte Ltd
Job Title Administrative Assistant
Company Location #04-32E, IMM Building,SINGAPORE
Duration Sep 2009 -Jun 2010
Scope/Responsibilities
• To maintain the Incoming and Outgoing documents in the company
• Screening the phone calls and transfer to the concern person.
• Collection of mails and distributing them to the appropriate individuals within the
organization.
• Monitoring and Maintenance of Company Vehicles.
• Making purchase for office stationery, getting quotation from the suppliers,
Generate Purchase Order, and follow up for the delivery of items.
• Filing & amp; Documentation
• Meeting Minutes Preparation and Arrangements
• Coordinating with different department within the organization
EMPLOYMENT HISTORY#3
Company Choon Huat Engineering Pte Ltd
Job Title Administrative assistant cum IT Executive
Company Location 6 Joo Koon Crescent,Singapore,SINGAPORE
Duration Apr 2008 -Apr 2009
Scope/Responsibilities
• Documentation &stamp; Filing of product related information.
• Software and Hardware Training to the staffs.

Elango Umarani July 20, 2016
• Designing and Documentation of ISO 9001 Procedure & Quality Manual
• Meeting Minutes Preparation and Arrangement
• Facility Management
• Product Master List Monitoring (Hard Copy & Soft copy)
• Report Generation
• Sales Coordination & amp; Product Presentation
• Generate Quotations, Invoices & Purchase Orders
EMPLOYMENT HISTORY#4
Company CARES Computer Education center
Job Title Programmer cum Computer Operator
Company Location CARES Computer Education center, Tamilnadu, INDIA
Duration Nov 2006 -Feb 2008
Scope/Responsibilities
• Project Evaluation and report submission
• Conducting seminars and training.
• Designing the Project & course module for students
• Preparation of monthly report on student’s enrollment, performance & amp;
activity.
CERTIFICATES
• Photoshop, Genetic Computer, Singapore, SINGAPORE
Acquired Date: Oct 2009
• VB.NET, CSC Computer Education, INDIA
Acquired Date: Dec 2007
• Tally, Tasoss Computer Centre, INDIA
Acquired Date: Jul 2007
• Visual Basic, Tasoss Computer Centre, INDIA
Acquired Date: Jan 2007
• C, C++, CARES Computer Division, INDIA
Acquired Date: Aug 2006
LANGUAGES/FLUENCY
Languages English
Speaking Proficiency: Reading & Writing
Medical Records/Terminology Proficiency: Medium
Languages Tamil
Speaking Proficiency: Reading & Writing
Medical Records/Terminology Proficiency: None

Elango Umarani July 20, 2016
PERSONAL DETAILS:
NAME : Elango Umarani
Date of Birth : 04-Oct-1985
GENDER : Female
MARITAL STATUS : MARRIED
RESIDENCE ADDRESS : Block 30, #15-87
Kelantan Road,
Singapore- 200030
LANGUAGES KNOWN : ENGLISH & TAMIL
PASSPORT No. : N0368980
PLACE OF ISSUE : Singapore
NRIC No : S8577433F (Singapore PR)
I declare hereby the above said information is true to the best of my knowledge
Date:
Yours Sincerely,
Place: Singapore Elango Umarani

Elango Umarani July 20, 2016
PERSONAL DETAILS:
NAME : Elango Umarani
Date of Birth : 04-Oct-1985
GENDER : Female
MARITAL STATUS : MARRIED
RESIDENCE ADDRESS : Block 30, #15-87
Kelantan Road,
Singapore- 200030
LANGUAGES KNOWN : ENGLISH & TAMIL
PASSPORT No. : N0368980
PLACE OF ISSUE : Singapore
NRIC No : S8577433F (Singapore PR)
I declare hereby the above said information is true to the best of my knowledge
Date:
Yours Sincerely,
Place: Singapore Elango Umarani