Quality Assurance Medical

ASIYA AFSHAN

#** ******* ******, *******, ** Road, Bangalore, India, 560076

Mob: 009***********

Career Objective

To contribute relevant research experience & academic background to a

challenging position in the field of IPR/ Regulatory affairs/Clinical

Research/Biotechnology/ Pharmaceutical/Life sciences/ Diagnostics research,

by joining an organization which can exploit the talent of a researcher up

to maximum by providing high profile job environment.

Present Status

Accenture Contract Medical Writer & QC Scientist for UCB Inc.

29 OCT 2009 - Present

. Within the timelines agreed, provide narratives and tables of contents

for use in clinical submissions following the format, style and content

in accordance with the applicable UCB SOP and the associated narrative

template.

o Perform quality assurance and quality control checks on each

narrative and table of contents such that it is "submission ready"

when delivered to UCB. Quality control checks involve, without

limitation:

o checking for incorrect data. For example, the information presented

is wrong compared with the data source;

o checking that all relevant information are included. For example,

medical history, concomitant medications;

o checking that information required by UCB's SOP and associated

template has been completed correctly;

o ensuring presentation of information is in accordance with the UCB

template;

o ensuring narratives are properly formatted as described in the UCB

template. For example, correct spacing, page breaks etc.;

o checking appropriate use of US or English spelling;

o checking grammar and punctuation, use of capitalized terms and

abbreviations.

. As part of the quality assurance process ensure that all data

inconsistencies between sources of information (e.g. inconsistencies

between data listings and safety reports, or medically relevant omissions

in data) are appropriately addressed and any issues or clarifications are

raised with UCB's Medical Reviewer;

. Incorporate all changes to narratives requested by UCB following medical

review by UCB. Where comments are not incorporated, Service Provider

will provide written reasons to UCB's Medical Director and/or Narrative

Writing Functional Lead.

. Participate in training on the UCB Systems (MIKADO) and use of UCB

narrative templates as requested; and

. Co-operate with the UCB Head Narrative Writing to resolve any issues

relating to the Narrative Writing Services.

. Previously, had been working as Associate Medical Writer II in SIRO

Clinpharm Pvt Ltd. one of the leading Contract Research organizations of

India

Core area of work at previous work place was medical writing, quality

review and quality check of clinical study documents of SIRO-J&J Global

Drug Development Centre at SIRO Clinpharm Pvt Ltd, Thane, India.

Job Responsibilities:

V Prepare Clinical Documents according to the Standard Operating

Procedures, Document Standards and Guidance document.

V Review statistical analysis plans and table/figure/listing.

V Ensure uniformity and consistency in the scientific content of the

regulatory documents.

V Revise the document as per the comments from the study team members.

V Prepare the clinical documents with required quality standards within the

target timelines.

V To work in coordination with the members in the study team for the

quality check of the clinical documents.

V Project timelines amongst the study team for the quality check of the

document.

V Perform the quality check of the clinical documents using the Clients

latest quality checklist.

V Send the annotated quality checked document to the author within the

timelines.

V To work in coordination with all the members in the study team- internal

and external for the development of clinical documents.

Summary of Academics

PG Diploma in Clinical Research, Trial and Administration from BII, Noida,

India.

[Course content: All the pharmaceutical/ biotech/clinical research related

regulatory affairs and complete details of clinical research trials and

administration, Clinical trails and Contract Research environment and

practices, ICH-GCP guidelines, ICMR guide lines for biomedical research

human research, Biostatistics and details of Schedule Y etc.]

Ph.D (Biosciences): Thesis submitted to Jamia Millia Islamia (A Central

University), New Delhi-25, India (2008)

Ph.D Title: "Molecular characterization of enterohaemorrhagic Escherichia

coli (EHEC) causing diarrhoea"

M.Sc in Biochemistry with 74% marks from the University of Kashmir, J&K,

India (year 2004)

B.Sc in Biology with 61% marks from the University of Kashmir, J&K, India

(year 2002)

10+2 in Biology with 62% marks from the J&K Board of School Education, J&K,

India (year 1999)

Ph.D. Research Summary: "Molecular characterization of enterohaemorrhagic

Escherichia coli (EHEC) causing diarrhoea"

Clinical samples were collected from the diarrheal patients of northern

India. Isolates of EHEC causing diarrhea in Indian children were

characterized and rapidly identified by using different microbiological and

molecular biology techniques. In antibiotic susceptibility tests, most of

the E. coli isolates were resistant to tetracycline > ampicillin >

streptomycin > kanamycin & nalidixic acid, > chloramphenicol > cefuroxime >

trimethoprim-sulphamethoxazole > cefotaxime & ciprofloxacin. It was also

noticed that imipenem is an effective antibiotic that can be used for EHEC

treatment since none of isolates was found to be resistant to the said

antibiotic. The results clearly indicate that the incidence of

antimicrobial resistance was widespread and probably resulted from either

the intensive use of antibiotics or the uncontrolled availability of them.

Plasmid DNA profile of isolates was analyzed and showed the presence of

more than one plasmid numbering from 1 to 3 having a molecular size > 23

kb. Conjugation experiment showed that all the antibiotic resistance

markers were transferable and their transfer frequency is highly variable,

i.e., 10-8 to 10-7. Among the transconjugants, all five strains were

showing resistance towards ampicillin, kanamycin, tetracycline,

chloremphenicol and streptomycin. Outcomes from conjugation test thus,

clearly showed the presence of most of the antibiotic markers on the

transferred (mobile) plasmids. Transformation was performed to check the

presence of antibiotic resistance genes on the mobile plasmids; and it was

demonstrated that all the antibiotic genetic markers were plasmid borne. It

can be inferred from our results that plasmids of all the selected strains

could transfer multi drug resistance to recipient strains. Sequence

polymorphism of eae gene, between different EHEC strains was investigated

to predict molecular evolution. Amplification and sequencing of eae gene

was performed; and gene sequences were aligned with the nucleotide

sequences already available in the GenBank database. All the eae gene

sequences were showing good homology (up to 98 %) with the intimin gene of

EHEC and with other variants of eae gene of EHEC. Phylogram tree was

generated from multiple alignments and it clearly indicates that most of

the bacteria have a different origin and they belong to different family.

Our results of multiple sequence alignment of nucleotides of all the 16

strains clearly indicated that there is a major divergence between the

sequences of eae gene fragment of the isolates used in this study. But few

of the sequences were very similar. With the help of bioinformatics

program, nucleotides were converted into amino acid sequences and all the

derived proteins were characterized with Prot-param program, and it was

found that all the products of eae gene fragments were showing similar

characteristics, means they all had a nearly similar MW, Amino acid

composition, theoretical pI vaules, instability index etc. Hence, in the

present research study, molecular characterization of EHEC was performed,

through multiplex PCR and conventional PCR; and detection of these genes

indicated various virulence associated potentials of the isolates as

indicated by the presence of eae along with verotoxigenicity (stx1 and

stx2).

Experiences

SIRO Clinpharm Pvt Ltd: Associate Medical Writer II (June 2009 to Oct 2009)

TATA Consultancy Services Ltd: Quality Check Scientist-Medical Writing

(June 2008 to June 2009)

Prior to registration in Ph.D, was associated with DST sponsored project

entitled "Molecular study of p53 tumor suppressor gene and its role in

gastric cancer" for six months.

Three years experience as a Research Scholar in the Department of

Biosciences (Gene Expression Lab) Jamia Millia Islamia (A Central

University) New Delhi. Topic of research: "Molecular characterization of

enterohaemorrhagic Escherichia coli (EHEC) causing diarrhoea"

Trainings & conferences

. Attended National Conference on Biotechnology organized by Biotechnology

Research & Education Society (BRES) in collaboration with Advanced Centre

for Biotechnology, Maharshi Dyanand University, Rohtak, Haryana on Aug 20-

21, 2007

. Attended Summer school on "Basic Genetic Engineering" organized by Asad

Ahmad, Prof. Emeritus at University of Alberta, Canada, at Faculty of

Science, Jamia Hamdard (Deemed University), New Delhi, March 19-23, 2006

Techniques Known

Microbiological Techniques: Isolation, Purification & Characterization of

micro-organisms, Culture Preparation (pure- culture), Growth curve

analysis, and Culture maintenance and shake flask level fermentation.

Biochemistry Techniques: Biochemical Characterization of Enzymes,

Qualitative and Quantitative estimation of proteins, lipids, glucose,

Cholesterol; extraction of glycogen from sheep liver, paper chromatography,

gel filtration, ion exchange chromatography, affinity chromatography, SDS

PAGE, RNA estimation, DNA estimation, Phosphate estimation, Chromatography,

Electrophoresis of proteins and DNA.

Molecular Biology & Genetic Engineering Techniques: DNA isolation, Agarose

Gel electrophoresis, Transformation, Ligation, Cloning, Plasmid isolation,

PCR, RT-PCR, SDS PAGE, Competent cells formation

Computer Awareness

Operating Systems: Windows 2000/98, XP. Vista

Other Tools: MS Office tools (MS Word, MS Excel, MS Power Point etc.),

familiar with Internet.

Bioinformatics Tools: Gene/Protein Alignment tools, Computational Protein

structure Prediction, etc.

Publications

Journals/ Research articles

Arif Ali, Asiya Afshan & Zahida Qamri "Drug Resistance in Indian isolates

of Enteropathogenic Escherichia coli", World Journal of Microbiology and

Biotechnology, 0959-3993 (Print), 1573-0972 (Online) 2nd August, 2008

Arif Ali, Asiya Afshan, & Zahida Qamri "Characterization of eaeA gene for

the rapid identification of Enteropathogenic Escherichia coli (EPEC)"

Journal of Infection (Communicated)

Asiya Afshan, Sonal Saxena & Arif Ali "Isolation, screening and

identification of enterohaemorrhagic Escherichia coli (EHEC) from stool

specimens of north Indian children" (Communicated)

Book Chapters

Asiya Afshan & Arif Ali "Diarrhoeagenic Escherichia coli: An Overview"

Biotechnology Emerging Trends, edited by R Z Sayyed and A S Patil,

Scientific publisher, Jodhpur, India, 2009, pp 203-210.

Abstracts

Md. Zeyaullah, S. Haque, S. Karim, S. Asad, A. Afshan, M. Soni, Md. R. Alam

& Arif Ali (2006) "Biotechnological applications of mer genes to mercury

detoxification and recovery", Association of Microbiologist of India, 47th

Annual Conference, "Microbiology: the challenges ahead", Barkatullah

University, Bhopal (MP) India - 462026

Asiya Afshan, Sonal Saxena, Pankaj Gosh, and Arif Ali " Screening and

identification of Indian isolates of Enterohemorrhagic Escherichia coli

causing diarrhea and amplification of its eae gene" Souvenir, Natural

Science Info Fest, Faculty of Natural Sciences, Jamia Millia Islamia, New

Delhi-110025, India, 2007 (28th feb-2nd march), pp-13-14

Sukhvinder Kaur, Majid Rasool Kamli, Md.Zeyaullah, Asiya Afshan & Arif Ali

"Isolation, Screening and Amplification of arsenate reductase gene (arsC

gene) of E. coli from arsenic contaminated sites in India" Souvenir,

Natural Science Info Fest, Faculty of Natural Sciences, Jamia Millia

Islamia, New Delhi-110025, India, 2007 (28th feb-2nd march), pp-12-13

Clinical Documents prepared:

> Clinical Study Report

1. Early phase study report (Phase 2)

Therapeutic Area: Infectious Diseases

2. Phase 1 study reports

Therapeutic Area: Metabolic syndrome and CNS.

> Clinical Trial Register (CTR) Summaries

Study summaries for public disclosure

Epidemiology studies (Observational)

Therapeutic area: Respiratory, Infectious disease, Oncology

> Clinical Pharmacology Study Reports

Phase 1 and 2 studies

Therapeutic area: Psychiatry, Neurology

> Narratives

Cardiovascular study: 43

Psychiatry study: Over 100

Oncology study: 46

> Clinical Overview

One Post Approval Document

Therapeutic area: Respiratory

> Quality check

Clinical study reports: 21

Investigator's Brochure: 3

Protocols: 3

Narratives: Over 200

Areas of interest

Biotechnology / Clinical Research / Pharmaceutical/ Life sciences /

Research and Development, Corporate Biotechnology/ Science, Biotechnology/

Pharma Regulatory Affairs/ IPR etc

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