Quality Assurance Data
Resume:
PAVANI
****.******@*****.***
• Have 1+ years of experience in Pharmaceutical and Healthcare Industry.
• Work experience with different phases of clinical trials, safety domains (demographics, dispositions, pre-
medication, concomitant medication, medical history, adverse events, lab data, physical examination, vital signs,
ECG) and efficacy data sets.
• Experience in CDISC (SDTM) mapping from raw datasets. Knowledge on FDA regulations and guidelines,
clinical trial practices, procedures and methodologies.
• Certified Base SAS Programmer for SAS®9
• Knowledge in Data Exporting and Data Importing of different file structures.
• Knowledge in SAS/BASE
• Knowledge in creating SAS tables, modifying SAS tables
• Have complete knowledge in different phases of clinical trials
• Experience in handling different type of laboratory Equipment Tablet Punching, U.V spectroscopy, I.R
spectroscopy, HPLC.
• Knowledge in Manufacture of microcapsules, Gelatin capsules
• Knowledge in packing of ampules
• Highly motivated individual with excellent organizational and interpersonal skills. Possess strong ability to
quickly adapt to new applications and platforms.
• Good experience in working cordially with the team members and with other related groups working in the
company.
• Ability to work on multiple projects simultaneously and meet the project deadlines
• Certified Base SAS Programmer for SAS®9
• Applications : MS Word, MS Excel, MS Access, MS PowerPoint.
• laboratory Equipment : Tablet Punching, U.V spectroscopy, I.R spectroscopy, HPLC.
• Operating Systems : Windows, Unix
Accenture/BMS (Oct 2013-
Till Date)
Role: Clinical SAS Developer/Analyst
• Working on End to End Clinical Data chain processing.
• Developed specification and Data sets by using Meta data and following CDISC ADaM Implementation Guide.
• Developed specification for different domains including Adverse events(ADAE), Physical Examination(ADPE),
Physical Measurements(ADPM),Medical History(ADMH), Disposition(ADSS), Demographics(ADSL), Vital
signs(ADVS), Electrocardiogram reports(ADEG),Laboratory Test(ADLB)
• Developed a New domain Specification Multiple Adverse Events(ADAEME) Based on multiple records of
Adverse Events (ADAE)
• Used CDISC knowledge to develop ADAM analysis datasets.
• Extensively used EntimICE /SAS procedures to create statistical summary tables, listings and graphs (TLGs) for
inclusion in Clinical Study Reports and regular submissions.
• Annotated CRF and helped to create data definition documents for ADAM datasets using CDISC implement
guidelines.
• Design and/or review analysis (ADaM) data structures and TLG(s)
• Create analysis (ADaM) datasets and TFL(s) as per spec
• Take instructions and perform tasks as necessary as directed by reporting manager.
• Develop and ensure specifications and documentation are correct and complete per client SOP and methodology
such as Detailed Level Design specs,
• In the agreed timelines per the Content Dev. WS Project Plan and ADaM Schedule and to high quality standards.
• Ensure SAS program output matches the requirements as per client related SOP/methodology such as the Detailed
Level Design specs.
• Participate in client facing workshops and Data Chain reviews of designs and build, ensure all feedback, changes
and updates are made in SharePoint per the ADaM Work Plan timelines.
• Work with other team members to ensure outputs are correct and complete.
• Organize, plan, and prioritize work to accomplish project objectives.
• Analyze information and evaluate results to choose the best solution and solve problems.
• Unit test objects.
Environment: EntimICE, SAS 9.2, Base SAS, SAS/SQL, SAS/MACROS, SAS/ACCESS, SAS/ODS, SAS/STAT,
SAS/GRAPH, MS EXCEL, MS ACCESS and WINDOWS
Hetero Drugs Pvt Ltd, Hyderabad, India (July2009-
June2010)
Clinical SAS programmer
• Worked in Phase I and II of Clinical Trials.
• Extracted the data from Excel files and created SAS datasets.
• Validate the datasets and compare the results to the source programmers output using PROC COMPARE
• Involved in preparation, developing data, analyzing, coding, report generation and testing programs according to
client’s requirements.
• Created the analysis data sets by manipulating the data according to the specification.
• Used existing macros as well as developed new SAS macros to create tables, graphs and listing for inclusion in
clinical study reports and regulatory submissions.
• Involved in preparing analysis plan, data analysis and statistical report writing presentations to FDA.
• Used frequently PROC TABULATE, PROC REPORT, PROC SUMMARY, PROC UNIVARIATE, PROC FREQ,
PROC ANOVA and PROC REG.
• Generated Ad hoc reports using SAS ODS engine and Proc SQL.
• Used SAS/ACCESS SQL Pass-Through Facility to access the data.
• Used SAS ODS facility with PROC Report procedure to generate reports in PDF and HTML formats.
• Used PROC ANOVA, PROC MEANS and other analysis procedures in generating real time reports.
• Involved in analyzing patient-reported outcomes for clinical studies for treatment of pain.
• Involved in complete validation of all the SAS programs used.
• Was involved in the documentation.
Environment: SAS/BASE, SAS/ACCESS, SAS/STAT, SAS/SQL, SAS/MACROS, MS EXCEL, Windows
UNIVERSITY OF BRIDGEPORT
Graduate Assistant International Student Services. (Aug2012 - May2013)
• Created Monthly Newsletters for International Student Services
• Conducted several events behalf of International Student Services
• Designed Templates and Flyers for promoting the events
• Helping international students
• Assisting International Student Advisors.
UNIVERSITY OF BRIDGEPORT
Student Worker International Student Services. (June2011 - Aug2012)
• Assisting International Student Advisors.
• Assisting International Students during orientation
• Front desk help
Hetero Drugs Pvt Ltd, Hyderabad, India (01June2009-
30june2009)
Research Intern
Worked in Manufacture of microcapsules, Gelatin capsules, packing of ampules, Quality control, Quality analysis, and
Quality assurance, Production departments where I was trained on coating of different tablets by using Film coating,
Enteric coating techniques and also in analysis of the Drug using HPLC.
• GRADUATE Program: Masters of Science in BIOMEDICAL ENGINEERING . GPA: 3.4
University of Bridgeport, Bridgeport CT.
MAY-2013
• UNDERGRADUATE Program: Bachelor of Pharmacy. GPA: 3.7
Jawaharlal Nehru Technological University, Hyderabad, India.
MAY-2010
• Master courses: Digital Signal Processing and Applications with the C6713 and C6416 DSK using MAT LAB
programing, Bio mechanics, Bio electronics, Bio tech science management, Tissue Engineering, Polymer
nanocomposites, biomedical materials and engineering
• Bachelor courses: Pharmaceutical Analysis, Pharmacology, Pharmaceutical Technology, Medicinal Chemistry,
Pharmaceutical organic chemistry, Bio pharmaceutics, Pharmaceutical biotechnology, Dosage Form Design.
Master Thesis: CONTROLLED RELEASE DRUG DELIVERY SYSTEM OF AN ANTI-ASTHMA DRUG
Asthma is primarily inflammatory condition generally for the treatment of asthma various types of drugs are given upon
their mechanism of action while choosing the bronchodilators which acts on β2–adrenoreceptor agonist. The objective of
this work is to formulate a controlled release drug delivery system where two tablets are packed together in a zero sized
capsule of terbutaline sulphate which has various bioavailability because of two different absorption one in acidic medium
and other in intestine.
Bachelor’s Thesis: DEVELOPMENT AND EVALUATION OF MICROPARTICULATE FLOATING DRUG
DELIVERY SYSTEM OF REPAGLINIDE. Where we developed a drug which helps the diabetic patients to reduce the
dosage frequency this is done by incorporating floating drug delivery system of the drug.
• Awarded Outstanding Involvement by a Graduate Student by University of Bridgeport Student leadership
Awards April 2013
• Awarded Most Dedicated Student Worker at University of Bridgeport International Student Services April 2012
• Academic scholarship from University of Bridgeport for 5000$ 2010-2012
• Won First prize for paper presentation on Human Inhaled Insulin at Jawaharlal Nehru Technological University
Hyderabad
• Won Second Prize for National level paper presentation at 56th National Annual Pharmacy Congress Ahmadabad
Dec 09
Contact this candidate