www.lambda-cro.com Lambda Therapeutic Research Ltd Ahmedabad, Chennai : Pharmacovigilance

[Admin]

Lambda Therapeutic Research
Website: http://www.lambda-cro.com

Designation : Executive/Asst. Manager/Manager- PHARMACOVIGILANCE

Job Description :
M.Sc/ B.Pharm/M.Pharm/ Ph.D/MBBS/MD with relevant experience in pharmacovigilance for clinical trials

Desired Profile :
M.Sc/ B.Pharm/M.Pharm/ Ph.D/MBBS/MD with relevant experience in pharmacovigilance for clinical trials

Experience :2 - 7 Years
Location :Ahmedabad, Chennai, Mumbai

Contact:
Lambda Therapeutic Research Limited
Human Resources Dept. Plot No-38, Near Silver Oak Club, S.G. Highway, Gota, Ahmedabad-380061
Ahmedabad,Gujarat,INDIA 380061

Email: ahmedabad@lambda-cro.com

Mumbai:
701, the Great Eastern
Summit 'A', Plot No. 56, Sector 15, CBD/Belapur, Navi Mumbai 400 614, India
Email: mumbai@lambda-cro.com

[Guest]

Dear Sir/Madam,
It has been a great experience to know about Lambda Therapeutic Research online. I look forward for working with this reputed company. Given a chance to work, I will do the best to my abilities for the development of the company and myself to bring it to the next level. I am forwarding my CV below. Hoping for a good start to my carrer as a fresher.
CURRICULUM VITAE
Contact Information
Name : Zishan Jalaluddin Shaikh
Address : 234, Sarvodayanagar, Sector-30, Gandhinagar, Gujarat-382030.
Phone No : 9016236312 (M), 079-32944557 (L)
Email ID : zishan_pharm7 AT yahoo.in
Academic and Educational Qualifications
No Class Percentage Institute University Year Place
1 SSC(10th std) 82.34 Mount Carmel High School GSHSC Board March 2003 Gandhinagar, Gujarat
2 HSC(12th std) 52.46 St.Xaviers High School GSHSC Board March 2005 Gandhinagar, Gujarat
3 1st year B.Pharm 79.60 NGSMIPS RGUHS, Bangalore Sep/Oct 2006 Mangalore, Karnataka
4 2nd year B.Pharm 68.78 NGSMIPS RGUHS, Bangalore October 2007 Mangalore, Karnataka
5 3rd year B.Pharm 73.38 NGSMIPS RGUHS, Bangalore Sep/Oct 2008 Mangalore, Karnataka
6 4th year B.Pharm 69.83 NGSMIPS RGUHS, Bangalore August 2009 Mangalore, Karnataka
7 5th year B.Pharm
(Honours) Sem IX 75.00 Institute of Pharmacy Nirma university June 2010 Ahmedabad, Gujarat
8 5th year B.Pharm
(Honours) Sem X Results awaited Institute of Pharmacy Nirma university Sept 2010 Ahmedabad, Gujarat
GSHSE – Gujarat Secondary and Higher Secondary Education Board
NGSMIPS – Nitte Gulabi Shetty Memorial Institute of Pharmaceutical Sciences
RGUHS – Rajiv Gandhi University of Health Sciences

Specifics for Grading System at Nirma University
Semester IX : Semester Performance Index – 7.50/10
Progressive Performance Index – 7.75/10
Semester X : Training at Apollo Hospitals as a Clinical Pharmacist.
4 months – 24th May to 4th September
Additional Training of 1. Basic Life Support
2. Basic Fire Fighting
Personal Information
Father’s Name : Jalaluddin J Shaikh
Date of Birth : 2nd September 1987
Place of Birth : Ahmedabad
Nationality : Indian
Sex : Male
Marital Status : Single
Languages Known : English, Hindi, and Gujarati
Interests : Reading Books, Novels, Informative Literature, Academic Journals
Sports : Chess, Basketball
About me : I don’t have much talents or knowledge, but I am a quick learner which makes me survive in any situation I am put to. I like to learn new things everyday and interacting with people is my pleasure. I don’t have much to say about myself but lastly I admire and love qualities such as patience and peace.
Declaration
I, hereby, declare that the above information is true to the best of my knowledge and I take full responsibility for the authenticity of it.

(Zishan J Shaikh)

[anu_niru]

Dear Sir/Madam,
It has been a great experience to know about Lambda Therapeutic Research online. I look forward for working with this reputed company. Given a chance to work, I will do the best to my abilities for the development of the company and myself to bring it to the next level. I am forwarding my CV below. Hoping for a good start to my carrer as a fresher.
CURRICULUM VITAE
Contact Information

CURRICULUM VITAE
Anusha.S,
mail :anusha.s.pg AT gmail.com

OBJECTIVES : Looking for a challenging career and willing to provide total support to the organization that I am in, with the capabilities I have, in order to achieve organization goals and create mutual benefit. To be successful and forerunner in the field, and to strive heard for the progress of the organization.
A goal oriented professional with 2 months of experience in QC.
Intrested towards Quality control or Analytical R&D
A team player with good communication, analytical and relationship management skills.


DETAILS :
Academic Performance :


Qualification Board/University Institution grade Year of completion
M.Sc., in Organic chemistry Kuvempu University Jnana Sahyadri,
Shankaraghatta,
Kuvempu University 1st class 2007-09
B.Sc (Chemistry, Zoology, Microbiology) Kuvempu University D R M Science College, Davanagere 1st class 2006-07
P.U.C Department of pre-university Education V K J PU College. 1st class 2003-04
S.S.L.C Karnataka Secondary Education Examination board. Vijay Marie English Medium School 1st class 2001-02
ACADEMIC PROJECTS :
“Synthesis and characterization of substituted phenylthiourea derivatives.”
In this project we have developed very simple and convenient method for the synthesis of various phenyl thiourea derivatives. All the compounds purified by recrystalisation with ethanol. Further the purity of these compounds was checked by TLC. All the newly synthesized compounds were characterized through 1H NMR and 13C NMR Spectroscopic techniques.
Instrumentation :
chromatographic technique : Trained with GC and HPLC.
spectroscopic technique : Trained by FTIR(Thermo scientific-NICOLET IS10)
other tecniques : Metrohm(808 titrando) and KF Titrator (795 titrando) with Autotitration, Autopolarimeter(Rudolph analytic research)

EXTRA CURRICULAR ACTIVITIES :
Participation; National conference on Nanotechnology : Past, Present and Future, held at Kuvempu University, Shimoga.
National conference on nanochemistry held at Sahyadri College Shimoga.

COMPETENCIES :
Communication & presentation skills, commitment to any work, adaptability, Eagerness.To learn new things.

STRENGTHS :
Dedication, friendly, desire to face tougher and newer challenges, Hard worker.

COMPUTER SKILLS :
Computer basic (Ms-world Ms excel, Ms Power point and internet), HRD Skills, Chemsketch.

[Jas kaur]

JASPREET KAUR
Clinical Research Coordinator and Clinical Research Professor
having 2 year experience in the field of Clinical Research
E-mail id : jas_21garcha AT yahoo.com ,

Objective
To work in a stimulating and challenging milieu that would facilitate the maximum utilization and application of my broad skills and expertise in making a positive difference to the organization in the field of Clinical Research.
Experience
- Previous Position summary :
Organization : Anovus Clinical Research (SMO) &
Anovus Institute of Clinical Research
Designation : Clinical Research Coordinator &
Clinical Research Professor respectively.
Tenure : 1 august 2009 to 1october 2010
Projects handled :
Crohn’s disease
Rheumatoid Arthritis
Acute Coronary Syndrome
Ulcerative colitis
Prostate Cancer
Knee/Hip Arthoplasty
Job description :
- Experienced in handling the BA/BE, phase 2, 3, and 4 studies.
- Assist PI in the communication of study requirements to all the party(ies) involved the study.
- Collects all the documents needed to start the study and update the master file till the close out.
- Maintain the original documents and the study timelines.
- Completes study documentation and maintains study files in accordance with sponsor requirements.
-Conducted Internal Monitoring
-To support the clinical research teams with ongoing conduct of studies.
-To assist project teams with study specific documentation as appropriate;
- preparing study-specific procedures
- drug accountability records
- completion of status reports
- study newsletters and merge letters, etc.-To become familiar with ICH GCP,appropriate
regulations and relevant SOP's.
- To assist in the preparation, handling and tracking of Ethics/Regulatory submissions.
-To process Case Record Forms i.e. log in, tracking, quality control as appropriate for the study.
-To assist in co-ordination of Investigator payments.
-To maintain the study files for the project.
-To co-ordinate ordering/dispatch and tracking of trial materials e.g. CRFs, diary cards, lab supplies,
drug supplies as appropriate.
-To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
-To assist in the tracking and distribution of safety reports.
- Assists the Principal Investigator in submission of accurate and timely closeout documents.
As a Lecturer :
- Preparing Clinical Research lectures and taking them
- Preparing Clinical Research notes for the students.
- Act as a Mentor for students in their internal ship.
- Editing the books for institute.
- Meta analysis of the articles.
- Conducting practical classes for better exposure towards the clinical research.
- Conducting workshops and conferences.
- Carries out administrative work
- 1st Job Summary :
Organization : Mohan Dai Cancer treatment and research foundation, Ludhiana, Punjab
Designation : Clinical Research Coordinator
Tenure : Aug 2008 to July 2009
Projects handled :
GBM/ Anaplastic Astrocytoma
Venous Thromboembolism
Metastasis breast cancer/ Metastasis colorectal cancer
Gastro-oesophageal cancer
Educational Qualification
- M.Sc. clinical research from Institute of Clinical Research in India, New Delhi affiliated from Cranfield University, UK (2007-09).
- PGDCA in Clinical management from Institute of Clinical Research in India, New Delhi (2007-08).
- B.Sc. Biotechnology from Punjabi university, Patiala, Batch (2005-07)
Extra curriculum activities :-
Participated in District level volleyball tournament in 2001-2002 in Ludhiana
Zonal level volleyball tournament in 2001-2002 in Ludhiana

[Guest]

Patel Dhaval
M.Pharm (Pharmacy Practice)
CAREER OBJECTIVE :
Aim to associate with an organization that gives me scope to apply my knowledge and skills along with my hard work and to be innovative and proactive in all work assignments and always explore new areas to learn and specialize in.

EDUCATIONAL QUALIFICATIONS :
B.Pharm from Rajiv Gandhi University of Health Science, Bangalore Karnataka with 1st Class (62.46%), Period 2004 to 2008.
M.Pharm (Pharmacy practice) Pursuing Master of Pharmacy in Pharmacy Practice, 2nd year, Jaipur National University, Jaipur, Rajasthan.
And 1st year passed with 1st class (63.0 %).
Higher Secondary (10+2) from GHSEB (Gujarat) in 2004.
Secondary (10) from GSEB (Gujarat) in 2002.
M.PHARM PROJECT WORK :
“Long term side effect of the Telbivudine in hepatitis b patients and its comparisons with the Lamivudine” under the esteemed guidance of Dr. Pankaj R Shah professor, institute of kidney disease and research center and institute of transplantation science, civil hospital, Ahmedabad (Gujarat) and institutional guidance of Prof. Manmohan Singhal H.O.D of Pharmacology and pharmacy practice at Jaipur National University- Jaipur (Rajasthan).
ACHIEVEMENT :
- Participate in poster presentation at Jaipur National University.
- Poster presentation in A.I.C.T.E sponsored national seminar at Raipur, Chhattisgarh.
Seminar attended :
- Attended the seminar of Pharmacovigilance by Dr. Vikas Vaishnavi, Head Clinical Research, Cadila Pharmaceuticals Limited at Nirma University Ahmedabad.
- Attended the seminar of Bioequivalence and Bioavailability by Dr. shailendra goswami vice president Cadila pharmaceutical limited at Nirma University Ahmedabad.
Seminar presented :
- Pharmacovigilance
- Clinical trials and CRO
- Nutraceuticals
- Osteoporosis

TECHNICAL SKILLS :
Computer Literacy : MS office, excel and internet surfing.
TRAINING DETAILS :
- Three Months Training at HELIOS Pharmaceutical PVT.LTD, Baddi, H.P. Training covered Production & Evaluation of different dosage forms (Tablet, Capsule ) QA, QC, Packaging & Dispensing.
- Three Month Experience in Production Department in HELIOS Pharmaceutical PVT.LTD, Baddi, H.P.
STRENGTHS :
- Registered Pharmacist.
- Innate ability to strike a rapport with customers, driven toward achieving results, continuous learning & self-assessment.
- Excellent temperament to work in a team, as well as coordinate between various activities.
- Assured stability for work.

[Guest]

Curriculum-Vitae
Anurag Dutt Sharma
Email id : anurag.dutt31 AT gmail.com
________________________________________
Objective : To achieve a challenging and creative position by using my interpersonal skills, analytical thinking, hard work, determination to contribute in the organization.
Summary :
- Six months internship in Clinical Data Management from Moksha Biosciences, Hyderabad.
- Ability to create Database for Clinical Trials using Oracle Clinical(OC).
- Ability to manage tasks like Discrepancy Management and Query Generation.
- Exposure to Clinical Data Management and Clinical Trial Process.
- Ability to load external Lab data into Oracle Clinical Database.
- Ability to extract data from Oracle Clinical to SAS.
- Good Comprehension of ICH GCP Guidelines.
Technical Expertise :
Oracle clinical and CDM Knowledge :
- Study Setup, Conduct and Close out
- Planning and Design of Clinical Trial Study
- Database Design.
- Data Validation and Derivation Procedures
- Data Entry
- Batch Data Loading
- Discrepancy Management.
- Database Closure and Locking.
- 21 CFR Part 11
Role and Responsibilities :
- Developed Database Objects using the current Global Library data objects Convention.
- Edit checks programming and validation.
- Loading Lab batch Data
- Issue Data Clarification Forms (DCF) as and when required.
- Track, review and close all DCF responses received.
- Exporting data from Oracle-Clinical into SAS.
- Validation of tables and Analysis Datasets.
- Perform Database Lock and Freeze.
- Review and Resolve discrepancies identified by the system or through manual checks
Clinical research knowledge and skills :
- Clinical research fundamentals
- ICH-GCP and Indian GCP
- Clinical trial designing
- Project planning and management
- Study startup process
- Clinical monitoring and essential compliance
- IEC/IRB submission or notification procedure
- Essential document writing and maintenance in clinical research and regulatory submission
Qualification :
- Advanced Post Graduate Diploma in Clinical Research from Imperial Institute of Clinical Research, Ahmedabad.
Class Board/University Marks
B.Pharmacy RGPV, Bhopal (M.P.) 62.5%
XII M.P.Board 60%
X M.P.Board 62.8%
Project undertaken :
Name of the project Project guide Year
Application Of Computers in Pharmaceutical Development Mr. Yasir mohammad (M.Pharm. Pharmacognosy) Jan.2010 to June2010
Computer Proficiency :
Knowledge of MS Office Suite (Word, Excel, PowerPoint),Internet, Knowledge of Windows based Operating Systems.
Industrial Training :
One month training in SAMSON PHARMACEUTICALS PVT. LTD.
Declaration :
I hereby declare that the above information is true to the best of knowledge and if you give me opportunity to work in organization, I will give my best.
Date : Signature
Place….

[Guest]

Respected Sir,
I am a Master of Science (Biotechnology) with experience of Quality Control at Span Diagnostics Ltd., Sachin. I would like to offer myself as a candidate for suitable post in your esteemed organization. I have enclosed my resume as a first step in exploring the possibilities of employment with your esteemed organization.
I shall be grateful if you could give me an opportunity to prove my caliber in your esteemed organization. This will help me to have excellent exposure to the highly sophisticated ambience of your organization and understanding the aspects. If given an opportunity, I assure you that I will work with full sincerity and enthusiasm and abide by the rules and regulation of the esteemed organization. Please find enclosed herewith my curriculum vitae for your kind perusal.
Looking forward for your positive reply,
Thanking you,
Yours sincerely,

Ruchita N. Shah
M.Sc. (Biotechnologist)
E-Mail : ruchita.shah AT yahoo.com
Professional Preface :
- A dynamic professional with 6 months of experience in Quality Control Department.
- Presently working as QC-Officer at SPAN Diagnostics Ltd, SURAT.
- Adept at handling day to day operations in co-ordination with internal / external departments for smooth business operations.
- An effective communicator with excellent relationship management skills and strong problem solving & organisational abilities.
Areas of Expertise :
- Work as per In Process Q.A., Finished product Quality Assurance and Quality Assurance check list.
- Carry out all Raw Material, In-process, Finished-product testing, Reserve/Retention sample testing.
- Issue Batch release Certificate after completed the study.
- Calibration of instruments.
- Stability studies of product as per ICH Guidelines.
- To report regularly and discuss all matters participating day to day activities of the new development carried out in the laboratory.
Accountabilities : Working knowledge of different instruments like U.V.Spectrophotometer, pH meter, Autoclave, Centrifuge, Autochem, Malvern Zetasizer Instument.
IT Proficiency : Conversant with MS-Office Applications (Word / Excel / PowerPoint), SAP.

Scholastics :
M.Sc. (BIOTECHNOLOGY)
Veer Narmad South Gujarat University. Surat in 2012
With higher second class
Dissertation Work : As a part of M.Sc. Biotechnology course I had successfully completed 3 months dissertation work at Entomoloy Department, Navsari Agriculture University, Navsari, Gujarat
Other Qualification :
- I have attended a conference on ‘Interdisciplinary Approaches in Environmental Science’ held at M.S.University, Vadodara.
- I have attended National Symposium on Recent Trends in Cellular Research held in Rajkot.
- I have attended a conference on ‘Continuous Medical Education on Haemophilia’ held at Bhagwan Mahavir College of Biotechnology, Surat.
- I have passed Biotechnology Aptitude Test-2012 with 71.42 percentile.
Personal Dossier :
Date of Birth : 23rd December, 1989
Linguistic Abilities : English, Hindi, Gujarati

[Unregistered]

Curriculum Vitae
Prashant Patel
Email : prashant_patel0337 AT yahoo.com

Date of Birth : Aug 28, 1987
Gender : Male
Marital Status : Unmarried
Languages : English, Hindi and Gujarati

OBJECTIVE :
To work in a highly competitive and motivated environment utilize the skills gained in academic time to its optimum use and succeed in field of marketing and help in development of company.

Education :
Master of Pharmacy in Dept. of PHARMACEUTICS, SHREE DEVI COLLEGE OF PHARMACY, MANGALORE under RAJIV GANDHI HELTH SCIENCE UNIVERSITY, KARNATAKA. June 2010 to May 2012 66.29%
Bachelors in Pharmacy, SRI NIVAS COLLEGE OF PHARMACY, MANGALORE under RAJIV GANDHI HELTH SCIENCE UNIVERSITY, KARNATAKA. Oct 2005 to Oct 2009 62%
CLASS XII VIVEKANAND HIGH SCHOOL, JUNAGADH, GUJARAT. 2005 62.31%
CLASS X ALPHA HIGH SCHOOL, JUNAGADH, GUJARAT. 2003 81%

Research undertaken :
FORMULATION AND EVALUATION OF ORAL STRIP OF ANTI-ANGINAL DRUG.

Computer Knowledge :
Basic knowledge of computer, MS Office, Internet Operating Skills.
CCC exam passed.

Career History & Accomplishments :
Seminars / Workshops Attended :
** National Level Conference of Innovative Trends In Pharmaceutical Research
** 62nd Indian Pharmaceutical Congress
** National seminar on advance medicinal plant research and herbal drug technology.
** 63rd Indian Pharmaceutical Congress.

Training (Graduate Level) :
Completed Training in JENBURKT PHARMACEUTICAL LTD, SIHOR, GUJRAT.

Others :
Strengths : Logical & Analytical Thinking Abilities, Hard Working, Self Motivated.
Hobbies & Interests : Learning New Technologies, Making Friends, Music.

[Unregistered]

Vijay Rafalia
Email : rafaliavijay AT yahoo.com

Seeking entry level positions with a growth oriented organization in the areas of :
Clinical research associates
Pharmacovigilance

Professional Profile :
Budding pharmacology professional with a post graduate degree in pharmacology from K.B. Institute of pharmaceutical education and research (KBIPER) Gandhinagar. Consistent academic record with zeal to learn and apply new concepts for achieving best results. Motivated and self-starter with a passion to succeed and desire to excel in the areas of clinical research, Pharmaceutical R & D and Clinical Data Management.

Academia :
K.B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat
Master of pharmacy, pharmacology, CPI7.20, 2010-1012,
Gujarat University, Ahmadabad, Gujarat
Bachelor of Pharmacy, 20062010, Class : First Class

Academic Achievements :
Awarded stipend of 8000 INR/Month for Two years, 2010-12 by AICTE, 2010-12.
Qualified GPAT-2010 conducted by MSU, Baroda in Pharmaceutical sciences
Successfully completed the distance learning in ‘General Course on Intellectual Property’ conducted by WIPO 2010

M.Pharm research project :
Project title “Role of TRPV1 in Enalapril induced hyperalgesia in Streptozotocin induced diabetic mice”.
Research guide : Dr. G.B.Shah
Scientific Expertise
o Blood pressure Measurement : A skillful hands on Carotid artery cannulation for measurement of Blood pressure in rats.
o Sound knowledge of Regulatory Guidelines : ICH-GCP guideline, ScheduleY
o Knowledge of ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS

Seminar Presented :
Currently used analytical techniques for measurement of physiological parameter; general aspect of uric acid, creatinine, electrolyte, urea.
Pharmacological Screening Model Of Cardio tonic
Seminar on Pharmacology Lab : Instruments

Professional Activities :
500 hours of training experience in Mamata Pharmaceuticals, Waghodia GIDC, Vadodara Gujarat in 2009-2010.
Worked in acute & subacute toxicity study of Sevelamercarbomate oral in rats and mice at K.B.I.P.E.R Gandhinagar.
Worked in acute toxicity study of Zoledronic acid injection in rats and mice at K.B.I.P.E.R Gandhinagar.
Worked in subacute toxicity study of Pregabalin i.m.& i.v. In rats at K.B.I.P.E.R Gandhinagar.

Extracurricular activity :
Actively participated in cultural and sports events during graduation and post graduation level
Actively participate in three days leader ship program, Gandhinagar in 2010

Computer Proficiency :
Scientific information retrieval using search engines such as Science direct, Pub Med, Scifinder, pubget, med scap.
Proficient in using Operating Systems and programs like Reference Management Software (End Note Plus) and MS Office
Statistical Application : Sound knowledge of statistical software Graph pad prism for analysis of data.

Personal details :
Date of Birth :31st January 1989
Marital status : single
Languages Known : Hindi, Gujarati and English

State : Gujarat

[Unregistered]

UMA RAJBHAI PADAYA
Email :umapadaya.7131 AT gmail.com

EDUCATIONAL QUALIFICATION :
B.SC FROM GUJARAT UNIVERSITY(2011)
INTERMEDIATE FROM HSEB IN THE YAER(2007)
SSC FROM GSEB IN THE YEAR(2005)
MLT completed from MEDIPLANET INSTITUTE.
M.SC IN MICROBIOLOGY RESULT IS AWAITED.
CERTIFICATE BY GSBTM SPNSORED NATIONAL CONFORENCE OFMicrobes AT MGSc2011

COMPUTER SKILLS :
Basic, MS office, D.T.P
PREFERENCE :
Industries preferred are pharmaceutical company & hospital
PERSONAL PROFILE :
NAME :
UMA RAJBHAI PADAYA
FATHER’S NAME :
Mr.Rajbhai Madhabhai padaya
MOTHER’S NAME :
Mrs.Hansaben rajbhai padaya
DATE OF BIRTH :
7th jan, 1990
NATIONALITY :
Indian

MARITAL STATUS :
Single
MOTHER TONGUE :
Gujarati
LANGUAGE KNOWN :
English,Hindi,Gujarati
HOBBIES :
Listening music,Dancing

DECLARATION :
I hereby declare that the abovementioned information is correct to my knowledge and I bear the responsibility for the correctness of the abovementioned particulars.

Place :AHMEDABAD
UMA RAJBHAI PADAYA.

[Unregistered]

Students Name : Mrs. Bijal Jani
E-mail : bijal_pandya2003 AT yahoo.com

Personal Data :
Date of Birth : sept. 30, 1988
Sex :
Nationality : Indian
Marital Status : Married
Languages Known : English, Hindi, Gujarati.

Career Objective :
To obtain a suitable position in a corporate organization, where my skills and knowledge will help me attain excellence and where the opportunities provided will lead to avenues for professional and personal growth.
To be recognized as a dedicated, quality oriented team leader, who can perform duties entrusted as per the profile designated and work with full determination to achieve results.

Clinical research knowledge :
Clinical research :
** Phases of CR, Ethics committee and IRB
** ICH GCP, Indian GCP, ICMR, Schedule Y
** IND, NDA, Informed consent process, subject selection
** Drug discovery and development
** Clinical trial design
** Sponsor, Investigator, Vendor responsibilities
** Site selection, initiation, close out, contract, budget
** Protocol design, SOPs, CSR, CRF design, review and SDV
** Site monitoring, Audit, Inspection

Pharmacovigilance :
** Expedited reporting requirements
** Regulatory aspects of PV, QA in PV
** ICSR case processing, Risk management, Medical evaluation of AEs Signal detection, PV database
** Signal detection, PV database
** PSUR, MedDRA, Narrative writing
** SAEs forms

Professional Qualification :
Academic Credentials University Aggregate :
PGDCRPV(Post Graduate Diploma in Clinical Research & Pharmacovigilance ) Cliniminds, Ahmedabad completed
Basic Qualification
Bachelor of pharmacy Rajeev Gandhi University ,Bangalore 60%completed

Practical Hands-on :
** Protocol designing
** Preparing Clinical Study Report (CSR)
** Preparing Case Report Form(CRF)
** Preparing SAEs(Serious Adverse Event) Form

Technical Skills :
** MS Office.
** Internet.

Strengths :
** Dedication
** Confident
** Hardworking
** Good team work
** Sincere
** Co-operative & goal oriented person
** Ability to work & thrive under pressure
** Eagar to know about new things & share to other

Declaration :
I hereby declare that the information given above is genuine to the best of my knowledge & if you give an opportunity to work in your organization, I will put my best efforts.
Place : Ahmedabad
Date : 11 /02/14
(Mrs. Bijal Jani)