clinical research, regulatory affairs, pharmacovigilance : Resume/ CV

[Guest Poster]

Personal Data :
Date of Birth : 24/06/1981
Sex : Female
Nationality : Indian
Marital Status : Married
Languages Known : English & Hindi.

Career Objective :
To achieve a challenging and creative position by using my interpersonal skills, analytical thinking, hard work and determination & to contribute in the growth of the organization.

Clinical research knowledge :
* Clinical Research fundamentals.
* ICH GCP, Indian GCP, ICMR Guidelines.
* Drug and Cosmetic act-Schedule Y, USFDA, European Union rules and regulations.
* Principles of Pharmacology & Drug Discovery & Development.
* Roles & Responsibilities of Key Stakeholder.
* Protocol development, Preparations & Planning for Clinical Trials.
* Essential Documentation filling & maintenance in Clinical Research & Regulatory Submissions.
* Clinical Trials Project Planning & Management.
* Monitoring essentials and checklists.
* Informed Consent process, enrollment, Case reports, Study reports, Source documents.
* Study Start up Process.
* Feasibility studies, Pre site visit, routine monitoring, adverse event reporting and Study close out.
* Drug & biological sample accountability, Coordination in investigational site
* Clinical Monitoring Essentials Compliance.
* IEC / IRB submission or notification procedure for approval of Study Procedure, Documents, Safety Reports / updates etc.

Professional Qualification :
Academic Credentials University Aggregate :
PGDCTM (Post Graduate Diploma in Clinical Trial Management)-student Cliniminds, Delhi.
B.D.S. Manipal Academy of Higher Education (MAHE) 66.6%

Professional Experience :
* Worked as a Lecturer (B.D.S.) in I.T.S. Centre for Dental Studies & Research, Muradnagar, Ghaziabad for 15 months from 11th March 2005 to 9th June 2006.
* As an independent practitioner at Bansal’s Dental Clinic, Rohini, Delhi for 9 months from 1st Oct. 2006 to 30th June 2007.

Practical Hands-on :
o Presentation on 21 CFR 312
o Presentation on Patents and IPR
o Protocol designed for a multicentric, randomised, double blind, double dummy, parallel & comparative design phase III study.
o Informed Consent Document designed for the same study.

Soft Skills :
o MS Word, Excel, Power point.
o Internet.

Strength :
o Self analytical understanding.
o Positive attitude in adverse situations.
o High degree of self thrust and motivation.
o Confident, strong will and easily adaptable to any environment
o Innovative thinking.

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 :
Date : (Dr. Parul Gupta)

[jignesh23272060@gmail.com]

CURRICULUM VITAE :
Jignesh patel
E-mail : jignesh23272060 AT gmail.com

Career Objective :
To establish myself as a successful employee in a challenging organization that gives me scope to enable further personal and professional development through the prosperity of the organization.

Educational Qualification :
Degree Institution University Year of pass Aggregate :
M.Pharm(Pharmacology) KLEU’s College of Pharmacy ,Belgaum.Karnataka KLE University, Belgaum 2011 72.87

Professional Diploma in clinical research:
(correspondence course) Catalyst Clinical Research , New Delhi - 2011 68
B.Pharm H.S.K college of pharmacy, Bagalkot, Karnataka RGUHS, Banglore 2008 68.52

PROFILE OF SKILLS :
Laboratory Skills :
- Ability to operate Bio-pac.
- Memorizing and organizing the stock of chemicals and reagents.
- Skillful in handling animals.
- Skillful in dosing the animals in different routes.
- Skillful in identifying drug action on different tissues.
- Skillful in collecting blood samples from animals.
- Skillful in maintenance of laboratory and equipment.
- Ability to work in a fast paced environment.
- Writing clear reports on the tests, data evaluated on animals and their behavior to various tests.
- Literature search in internet database

Instrumentation Skills :
- Operating Bio-pac, UV-Spectrophoto meters, Auto analyzer, Electrophoretic chamber, different invivo testing apparatus(langendroff’s apparatus,MES, Photo acto meter, Elevated plus maze, Hot plate etc.).

Software Proficiency :
- Operating System : Windows 7, Vista, Windows XP, and Windows 98.
- S/W Packages : MS-OFFICE (Outlook, PowerPoint, Word, Excel, Access).

Strengths :
- Adaptable to any environment.
- Positive Attitude and Self-motivated.
- Listening to others.
- Skillful in troubleshooting.

M.Pharm Project :
- Title :
Cardioprotective potential of ethanolic extract of Punica granatum flower in isoproterenol induced myocardial ischemia in Wistar rats

Publications :
- Evaluation of concomitant treatment of Simvastatin and Zingiber officinale in Doxorubicin induced cardiotoxicity in Wistar rats in International Journal of Research in Ayurveda and Pharmacy.
- ‘Cardioprotective effect of aqueous extract of Punica Granatum flower extract in isoproterenol induced myocardial infarction in Wistar rats’- in International research journal of pharmacy.

Training Undergone :
- Attended National Seminar on “CURRENT TRENDS IN PRECLINICAL AND CLINICAL VALIDATION OF TRADITIONAL MEDICINE”, organized by B.V.V.S’s H.S.K college of pharmacy, Bagalkot, held on 18th and 19th August 2007.
- Successfully completed ICH-GCP training in a workshop on “GOOD CLINICAL PRACTICE” held at KLES Dr. Prabhakar Kore hospital & MRC, Belgaum om 10th November 2010.
- Attended the 3RD CONGRESS ON COSMETIC TECHNOLOGY (FUTURE TRENDS IN COSMETIC TECHNOLOGIES) organized by KLE University and indian cosmetic technologists Association, held on 28th &29th August 2009.
- Attended the CME on “ARRHYTHMIAS AND ITS MANAGEMENT”
Organized by K. L. E. U’s Jawaharal Nehru Medical College and Indian Pharmacological Society Belgaum Branch, Belgaum, held on 26th November 2009.
- Attended the CME on “CLINICAL RESEARCH”. Organized by K. L. E. U’s Jawaharal Nehru Medical College, Belgaum, held on 20th February 2010.

[vijay bhalchandra chaudhari]

PRODUCTION CHEMIST FOR TABLET MANUFACTURING. (APPROVED)