House No.: *B/*A,

N.I.T. Faridabad

(Haryana)

Mobile: 989*******

ac0a2e@r.postjobfree.com

CAREER OBJECTIVE:

To be a part of professional groups with a challenging working environment as well as the learning experience. Add-on utilizes my knowledge and experience in research field to add value to the organization to the best of my efforts.

PROFESSIONAL QUALIFICATIONS:

Year of Passing

Degree/Class

University/Board

2011

M. Sc (Biochemistry)

Vinayak Mission University

2005

PGDCR

Academy of Clinical Excellence, Mumbai

2003

B. Pharmacy

Jamia Hamdard

1997

D. Pharmacy

Haryana, AICTE

1994

10+2

C.B.S.E.

1992

10th

C.B.S.E

PROFESSIONAL EXPERIENCE:

TOTAL WORKING EXPERIENCE: 11+ Years

Present Working Profile as Assistant Manager: 5 years

Currently working as a Senior Research Scientist-Medical Affairs in R & D II, Jubilant Generics Limited, Noida since January-2012.

Monitoring Bioequivalence studies.

CURRENT JOB DESCRIPTION:

Coordination with team handling the clinical studies. Milestone tracking of the progress of our BE studies with our service provider with an objective to expedite deliverable and ensure study completion as per assigned targets.

Leading the project team and providing strong leadership, proactive project management, and good communication links. Despite frequent change as necessitated by changing priorities and changes in upstream milestones, efficient slotting and prompt communication has ensured timely slotting of BE studies.

Review and finalization of clinical study protocols of pilot and pivotal bioequivalence studies as per various regulatory requirements. More than 400 bioequivalence protocols are reviewed.

Monitoring of Clinical phase of pilot and pivotal bioequivalence studies. More than 350 clinical phases are monitored that require out-of-station travelling to proactively ensure compliance to the study protocol, ICH-GCP guidance, regulatory requirement.

Responsible for all activities related to the BE study management and performs protocol related training mock sessions.

Review of draft and final clinical study report before handling it to DRA colleagues for regulatory submission.

Perform source document verification as per monitoring plan and ensure that source documents & other trial records are accurate, complete, kept up-to-date & maintained according to applicable SOP's to avoid incomplete records.

Take care of operation aspects of pilot and pivotal BE studies.

Co-ordinate investigational product supply to CROs.

Organize timely submission of regulatory documents for BA/BE studies protocols for BE NOC application to DRA colleagues for onward submission to DCGI.

Past Working Profile: 5 years six months

Worked as a Senior Research Officer in Fortis Clinical Research Ltd. Faridabad (Haryana) since Sep-2006 to 29-Jan-2012.

Medical writing of Bioequivalence studies protocols.

JOB DESCRIPTION:

Preparation and review of protocols, CRFs, ICDs as per various regulatory and sponsor requirements.

Responsible for all activities related to the protocol management and performs protocol related start-up activities.

Assist Principal Investigator in study start-up activities (IEC approval of the protocol & coordination meetings with IEC members).

Coordinate with the sponsor regarding the protocol preparation in compliance with regulatory regulations, ICH/GCP guidelines and the company SOPs and resolve the QA findings, within given timelines.

Preparing and submitting Regulatory documents for BA/BE studies for BE NOC application as well as assist investigator for SAE reporting to DCGI.

Executes other duties as may be assigned by the Clinical Operations Management.

Liaise with the other sectional heads for the efficient functioning of the organization.

Responsible for review of relevant standard operating procedures as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements.

Past Working Profile: 1 years six months

Worked as a Pharmacist in HelpAge India from 03-Feb-2003 to 28-Sep-2004.

PROFESSIONAL ACTIVITIES:

Attended 2 day work shop on GCP from Lotus Clinical Research, India.

LEADERSHIP, SPORTS AND EXTRA CURRICULAR ACTIVITIES:

Knowledge of computer proficiency (Word / Excel / Power Point).

Successful clearance of audits from ANVISA (Brazil), MHRA (UK), AFFSAPS (French & Danish), US FDA.

Other interests include music, reading and Traveling.

AREA OF INTEREST:

Clinical Research and Project Management.

SPECIFIC STRENGTHS:

Good knowledge of medical terminology.

Good skills in organization and time management.

Good problem solving skills.

Able to work independently and in a team environment

Good project management skills.

Basic understanding of ICH-GCP guidelines and drug development process.

BRIEF PEN PICTURE:

Name : Parveen Kumar Arora

Father’s Name : Shri S.L. Arora

Mother’s Name : Late Smt. S. Kumari

Sex : Male

Languages Known : English & Hindi

Permanent Address : 1B/9A, N.I.T. Faridabad,

Haryana – 121001

India

REFERENCES:

Dr. R. K. Khar (Head of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New delhi-62)

I hereby declare that all particulars furnished by me are correct to the best of my knowledge. With above submission, I do hope you will consider my candidature and call me to appear before you.

Place: Parveen Kumar

Date:

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