Clinical Trial Analyst Delhi/NCR : Medical KPO

[deepika]

Company Profile
The company caters to the requirements of the R & D needs of Pharma companies overseas. The candidates who apply for this must have expertise in Analysing Data of Clinical Trials & in writing Medical Reports as well as in writing Drug applications

Company Name:
Our client is a Medical KPO in Delhi NCR that wants Clinical Trial Analysts

Experience: 2 - 7 Years
Location: Delhi/NCR

Job Description
To manage projects in a Medical KPO in Delhi NCR that caters to the requirements of the Pharma industry overseas.Candidates must have excellent experience in Analysing Data based on Clinical Trials that are conducted by the large Pharma MNC's

Desired Candidate Profile
MBBS or Degree in M Pharma with 2 to 8yrs experience in Analysing Data received after conduct of Clinical Trials for drug formulations by Pharma MNC's in the USA & Europe. Candidates must have excellent track reccord of writing Medical Reports

Email Address: jrv@vsnl.com
Telephone: 91-0124-4107719,4107721

[vijendratomar]

Respected Sir,
Myself Vijendra Singh Tomar persuing M.Pharma from R.N.S College Of Pharmacy affiliated to RGTU, Bhopal (M.P).
I will complete my M.Pharma after completion of my project Work.
Presently, i complete my I year. Can I work as trainee in your company & doing my project from there.
If there is any vacancy, Please keep me informed about that.
I am very greatfull to you.
Thanks..
Your's Sincerely,
V.S.Tomar
(M.Pharma)

[Guest-IJT]

Hi,


I have 2.5 yr work experience in Nair Hospital, Mumbai (for WHO & DCGI project of ADR monitoring )and Reliance clinical research services, Mumbai India in Pharmacovigilance department.

Please view my CV/Resume for consideration for any vacancy in Pharmacovigilance team.

Best Regards

Neelam Mahaparale

SUMMARY

I have 2.5 years of experience in Clinical research with skills in Clinical operations, Pharmacovigilance & Data management which gave me excellent knowledge of GCP and ICH guidelines, Microsoft Windows, Microsoft office.

My work for ‘Adverse Drug Reaction (ADR)’ Monitoring Program governed by WHO and Drug Controller General of India (DCGI), helped me gaining exceptional knowledge in Pharmacovigilance domain.

As I have worked for hospital as well for CRO has good knowledge of working procedures for both Principal Investigator and Sponsor. My knowledge is excellent not only in clinical but also in Preclinical studies and patent law.

To enlist some of work responsibilities:
Pharmacovigilance:
--Medical monitoring plan writing
--Operational support in AE management to Clinical Operations group
--SAE collection, evaluation, classification and reporting
--Medical Monitoring Plan writing
--SAE reconciliation

Clinical operations:
--Feasibility survey
--Assistance in preparation of local study related documentation including Clinical Study Timelines, recruitment plans and Informed Consent Form
--Support for planning and execution of studies
--Coordinate supply of clinical study equipment/ drugs
--Review adherence to SOP and GCP
--Submission and archival of study documents

Data Management:
- Preparation of study related documentation & Timeline,
- To ensure Statistical Analysis Plan (SAP) requirements
- SAE Reconciliation
- Coding of adverse events (MedDRA)
- Medical Coding - Coding of concomitant drugs (WHODRUG)
- Data Validation and Query Management
- Periodic validation of CRF data

PROFESSIONAL EXPERIENCE

1) Reliance Clinical Research Services Pvt. Ltd.
(December 2004- April 2006)

Designation: Executive Medical affairs
(Pharmacovigilance Associate & Clinical Data Coordinator)

Clinical Research Experience:

Indication of study / Disease Role(s) in study
Oncology Safety Officer / Pharmacovigilance Associate
(SAE collection, evaluation, classification, and reporting)
Clinical data coder
(Coding clinical data SAE reconciliation)
Oncology Safety Officer / Pharmacovigilance Associate
(SAE collection, evaluation, classification, and reporting)
Oncology Safety Officer/ Pharmacovigilance Associate
(SAE collection, evaluation, classification, and reporting)
Probiotic formulation in Nephrology Safety Officer/ Pharmacovigilance Associate
(Medical Monitoring Plan writing, SAE collection, evaluation, classification, and reporting)
OTC product in Osteoarthritis Pharmacovigilance Associate
(MMP Writing, SAE collection, evaluation, classification, and reporting))
Ophthalmology Pharmacovigilance Associate
(SAE collection, evaluation, classification, and reporting)
Vaccines Pharmacovigilance Associate
(Medical Monitoring Plan writing)
Cardiology Pharmacovigilance Associate
(Medical Monitoring Plan writing)
Infectious Diseases Pharmacovigilance Associate
(Medical Monitoring Plan writing)
Respiratory Feasibility
Wound healing Clinical Data Coding and SAE Reconciliation
Ophthalmology Clinical Data Coding and SAE Reconciliation

2) Clinical Pharmacology Department, Nair Hospital, Mumbai.
(From January2004 to December2004)
Designation: Research Associate.

- ‘Adverse Drug Reaction (ADR)’ Monitoring Program governed by WHO and Drug Controller General of India
- Drug Information Services.
- Assistance in a Clinical Trial.
- Therapeutic Drug Monitoring
- Anti-Epileptic Drugs
- Immunosuppressant (Cyclosporine)
- PEG estimation in Urine using Spectrophotometer.

Clinical Research Experience:

Indication of study / Disease Study type and phase Role(s) in study
Diabetes Mellitus Phase I, ICMR sponsored Study Coordinator
Alcoholic Cirrhosis Phase III, CDRI Sponsored Study Coordinator

Workshop Attended:

- 2 Days state level work shop on Intellectual property rights – a pharmaceutical perspective 23th& 24th Feb. 2010
- Pharmacovigilance- a solution to drug safety, 13th Feb. 2010
- Pharma Pulse confluence Advanced Clinical research & GCP Workshop, 26th& 27th Feb. 2005
- Pharma Pulse confluence Pre-Clinical research, 24th& 25th Feb. 2005
- ICMR Workshop on Clinical Research Methodology, 2004.

Personal information
Nationality Indian

Education
Course Year of Passing Subject / Specialization Institution / University
B. PHARMACY 2002 Pharmaceutical Sciences Bharati Vidyapeeth’s College of Pharmacy/ Mumbai
PGDCRP
(Post Graduate Diploma in Clinico-Regulatory and Patents) 2005 Clinical Operations, Regulatory Affairs, Patent Law. R. N. Ruia College-PEXA (Pharmaceutical Experts Association) / Mumbai.

Languages Known

- English Business to Native level
- Japanese Basic level
- Hindi Native level
- Marathi Native level

References

- Dr. Urmila Thatte (Clinical Pharmacology Dept. K.E.M.Hospital Parel, Mumbai)
- Dr. Mahajan (Cardiology Dept, Sion Hospital, Mumbai)

[Guest]

SHAILZA SACHDEVA
E-Mail : shailzasach AT gmail.com

Completed B-Pharmacy from Guru Nanak Dev University,Amritsar in 2009, currently Pursuing M-Pharmacy (2nd year) from Punjab University, Chandigarh. A self-motivated team player with excellent communication, analytical, relationship management and problem solving skills. - Experimental projects on Pharmaceutical preparation like Manufacturing of Drugs and extraction of medicinal oils.

- Experimental projects on pharmacological effects on laboratory animals.

- Experiments on muscle reflexes of animals in response to drugs.

- Dissolution apparatus handling

- Disintegration apparatus handling

- Thin layer chromatography

- Column chromatography

- BIOPAC system- ECG monitoring

- Experiments on synthetic aspects of organic chemistry.

- Qualified GATE ENTRANCE EXAM in year 2009 with 91 percentile.
- Pursued “General course on Intellectual Property Rights” from the institute WIPO (dl-101) under the board WIPO, Geneva, Switzerland
- Summer internship-training at “Jackson Pharmaceuticals, Amritsar” for 4 weeks in production division during June-July 2007-2008.
- Live project-research on inflammation, cancer and related parameters.
- Active participation in all events throughout school and college level

- Member of “Association of Pharmaceutical Teachers of India (APTI)” (Previously member of Indian Pharmaceutical Association).

- Certification of Tycoon-The talent Hunt organised by career Launcher in Amritsar.

- Member of Placement Committee for B.Pharma Department.

- Awarded Scholarship from State Bank of India for academic achievements.

- Certification of excellence for active participation in TB Awareness Campaign held by IPA STUDENTS FORUM in 2008.
- Certification of Distinction in B-Pharmacy.
- Appeared for PTSE (PHARMACY TALENT SEARCH EXAMINATION) and secured 73 rank in all over india.
- Participation certificate as delegate in CHASCON-2010.
- Acceptance of paper entitled “Design, in Silico screening and synthesis of some novel fused pyrimidine derivatives as A2B adenosine receptor antagonists.” and presented the same in INDIAN PHARMACEUTICAL CONGRESS (IPC) IN Dec 2010.
- Acceptance of paper entitled “Design, Synthesis and evaluation (in vivo) of some novel thiazole derivatives for their anti-inflammatory activity. And presented the same in R C PAUL INTERNATIONAL CONFERENCE ON EMERGING TRENDS IN CHEMISTRY IN FEB 2011.

[Guest]

CURRICULUM VITAE
Gurdeep Singh Niranjan Singh
Current Address Email : singhgurdeep.1988 AT gmail.com
Flat No : 405 Shiv parvti apartment
Ratnadeep Colony near Dange Chowk
Pune 17
Objective
I would like to enter into doing the work of testing, Research, and development, which would help in the advancement, and development of the reputed firm for which I would be working for. My aim in favor of the company would be to invent and discover new medicines for the prevalent disease.
Educational qualification
Bachelor of Pharmacy
Examination University/
Board Year of Passing Percentage of Marks Class/Division
B.Pharm PUNE Appear Appear Appear
D.Pharm MSBTE 2006-2008 73.3 Distinction
H. S. C. Maharashtra Board 2004-2006 65.5 First
S. S. C. U.P. BOARD 2003-2004 59.3 Second
MSBTE : Maharashtra State Board of Technical Education Mumbai.
U.P. Board : Madhyamik Shiksha Parishad Uttar Pradesh.
Summer Internship Training
Company Name : Concept Pharmaceutical Ltd.
Place : Aurangabad
Unit : Compression
Extra Curricular Activity
- A paper presented on the Micro scale Experimentation on a Variable Trade in Chemistry.
- A paper is presented on the Education Regulation of Diploma Course in Pharmacy.
- Win a Parma quiz competition held by MSBTE.
Project :
Understanding the sexuality in context of HIV/AIDS in college youth of Pune India.
Areas of Interest
- Production
- Research &Development
- Quality Control
- Formulation
Computer proficiency
- Office Tools : MS Office.
- Basic : Computer
Strengths :
- I believe in maintaining high standard of work.
- Good Team Work With Positive Approach.
- I believe in sincerity and dedication the execution of the work given to me.

[Guest]

RESUME
Firasath.s

Email :shaiksfirasath AT yahoo.com

CAREER OBJECTIVE :
To prove myself dedicated, worthful and energetic as a Clinical data Programmer (CLINICAL DATA MANAGEMENT) in a progressive organization where my skills can be effectively utilized and which offers excellent opportunities to progress and be a member of a team that dynamically works towards success and growth of the organization.
PERSONAL SKILLS :
Ability to take initiative, work in team environment, self motivation, competitive spirit, comprehensive problem solving abilities, willingness to learn more.
PROJECT DESCRIPTION :
Tuberculosis (TB) is a disease caused by bacteria called Mycobacterium tuberculosis. The bacteria usually attack the lungs. TB bacteria become active if the immune system can't stop them from growing. Gene products involved in controlling vital aspects of mycobacterial metabolism and cell wall synthesis would be attractive targets. Trehalose is present as a free disaccharide in the cytoplasm of mycobacteria and as a component of cell-wall glycolipids implicated in tissue damage associated with mycobacterial infection. Transferase protein is present in mycobacteria, used in controlling the cell wall synthesis. The trehalose inhibitors are docked with transferase protein in GOLD software.
By calculating the binding free energy, the lowest energy inhibitor is used against TB after clinical trials.
ACADEMIC PROFILE :
Course
University
College/Institution
Year of passing
Percentage
M.Sc.,
Bioinformatics Autonomous Auxilium College
(vellore) 2007-2009 78%
B.Sc.,
Biotechnology SVU
Tirupathi. P.V.K.N. Govt., College, Chittoor. 2004-2007 68%
Intermediate Board Of Intermediate Education, Andhra Pradesh. Adarsh vidhyarthi junior college, Chittoor. 2002-2004 80%
S.S.C Board Of Secondary School Education, Andhra Pradesh. Indian school of English,
Chittoor. 2001-2002 70%
TECHNICAL SKILLS :
Operating Systems Windows-98/00/XP.
Databases DCA, C++,oracle, perl, D.T.P,
CDM(Clinical Data Management).
EXPERIENCE :
I worked as a customer care executive in TBSS(TATA Business Support Services) for
4 months in 2010 at begumpet,Hyderabad.
STRENGTHS :
- Planning and organizing skills.
- Positive attitude with an amiable disposition.
- Strong communication and technical skills.
HOBBIES :
Listening Music,cooking and watching TV.

[Guest]

RICHA NAGPAL
nagpalricha13 AT gmail.com
Career Objective
To build my career in the field of pharmaceutical research and want to achieve a position which will help to refine my skills and provide an opportunity to learn and grow in future.
Educational Qualification
Course Institute/College University/Board Marks Obtained Year
M. Pharma M.J.R.P. University M.J.R.P. University 77.1% (Till date) 2011
B. Pharma B.S.A.I.P. Faridabad M.D.U 74.3% 2009
12th Delhi Public School, Faridabad C.B.S.E 76.2% 2005
10th St. Anthony Secondary School, Faridabad C.B.S.E 82% 2003
Field/Training Inputs
- One Week induction in Ranbaxy Laboratories to understand Production & Research Operations
Professional Skills
- Basic Knowledge of MS-Office
Extra Curricular Activities/ Achievement
- 61st rank in National Level Pharmacy Talent Search examination
- Participated as delegate in 60th and 61st I.P.C
- Lifetime membership of I.P.G.A. (membership no. ALM-3847)
Project
Eight months (August 2010-March 2011) project for dissertation submitted to the Department of Pharmacy, MJRP University, Jaipur in collaboration with Clinical Pharmacology Department, Fortis Hospital, Noida on “Drug use evaluation study in a tertiary care Corporate Hospital with special focus on usage of antimicrobial agents in Inpatient department” under the supervision of Dr. Usha Gupta (Nodal Corporate Resource for Clinical Pharmacology & Management of Medication) Division of Clinical Pharmacology.
- Learning Experience :
Besides doing my project which was on Study of Antimicrobial Usage Pattern and Surgical Prophylaxis survey I learnt
- Monitoring Adverse drug reactions both by intensive and spontaneous method
- Monitoring Medication Errors both by intensive and spontaneous method & doing its root cause analysis
- Prescription Auditing & calculating the completeness of prescription and percentage of antibiotic usage
- Calculating Defined Daily Doses for Antimicrobial Agents being consumed in the hospital