Sumit Kumarsumitchand699@gmail.com (Mobile): +91- 8983780289/+91-08809162307

Career Objective:

To work in the Pharmacovigilance/Clinical Research organization and explore the available opportunities in drug safety and case processing and narrative writing.

Work experience:

(From 10thJun-2014 – Till date: Sciformix Technologies Pvt Ltd, Pune)

Period: 15-Jan-2014 - PresentOrganization: Sciformix Technologies Pvt Ltd, PuneDesignation: Safety Data Analyst (Quality reviewer) Job Profile:

Database : SCEPTRE

Responsible for the quality review of spontaneous, legal and literature cases. Quality involves 100% compliance to the client SLA to achieve optimum quality.

Prioritization of the cases (low, medium, high and immediate) on the basis of reported adverse event, seriousness criteria and ICH date.

Scientific assessment: Assess appropriate labeling documents for company products and create company opinion of causality.

Query management: To interact directly with client to solve case related issues and queries and respond queries of safety physician arising during processing of cases.

Providing the training to the entire new batch and reviewing their performance and updating the monthly grades of case processors.

(Also working as a backup submission specialist since last one year: Electronic and manual submission by using LCRx as database)

Period: 10-Jun-2013 to 15-Jan-2014 Organization: Sciformix Technologies Pvt Ltd, PuneDesignation: Safety Data Analyst (Case Processing) Job Profile:

Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in safety database (SCEPTRE).

Ensure scientific rigor through accurate, complete and consistent data entry of adverse eventreports from source documents with emphasis on timeliness and quality.

Doing Labeling (checking for expectedness in the reference safety information sheet for that specific drug).

Identify clinically relevant information missing from case report and facilitate its collec-tion (inconsultation with medical staff as required) by preparing follow-up request as needed.

Mentoring new-hires as designated by the project manager.

Be responsible in meeting timelines, and quality standards. Effective communication with Local Safety Officer/Business partner as per requirement.

Previous Organization: Organization: Cognizant Technology Solutions, MumbaiDesignation: Junior Data Analyst (Case Processing)Period: 04 July 2011 – 24 May 2013 Job Profile:

Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in safety database (ARGUS).

Assess and process all case types. Prepare initial and follow up case narratives. Split and merge cases by analyzing cases for specific criteria and cross-referencing split

cases. Collection and reporting of safety information. Mentoring new-hires as designated by the project manager. Be responsible in meeting timelines, and quality standards.

Educational Qualifications:

Post graduate diploma in clinical research and management from CREMA-Hyderabad affiliated with Jaipur Nation University: 2010-11.

M.Pharm (Pharmacognosy) from SRM College of Pharmacy, Chennai: 2008-10 B.Pharm from AAIDU, Allahabad: 2004-08

Industrial Training:

One month industrial training at Signa Pharmaceuticals Pvt Ltd, Kanpur (In year 2007).

Project Works:

“Pharmacognostical Standardization and Evaluation of seeds of Punica granatum L. as

skin cosmeceutical.” – Dissertation work as part of M. Pharm curriculum.

Research Publication:

“Antioxidant and tyrosinase inhibitory activity of aqueous extract and oil of seeds of Punica granatum

L. (Punicaceae)” in International Journal Of Science And Nature (IJSN)

Extracurricular Activities:

Attended the National Pharmacy week Celebration & 2ed IAPST Annual National

Convention 2008. The theme was “Future direction and guidance to the universities and

institution to plan prosperous pharmaceutical research”.

Attended the National level Symposium on Newer Technology In Pharmaceutical

Education And Industry at Madras Medical College, Chennai-600003

Attended the one day orientation Program on Employability skills at SRM University Chennai organized by SRM College of pharmacy and Tamil Nadu Inpharm association.

Computer Proficiency:

Good working knowledge of M.S office (Microsoft Word, Excel & PowerPoint) Typing Speed: 32 WPM with 95 % Accuracy.

Hobbies:

Travelling Singing

Personal Details:

Date of Birth: 1st March 1982.Present Address: Room No.B/204, Sahil Heights, Pimple Nilakh, Pune- 411027 Marital Status : MarriedLanguages Known : English and Hindi.Permanent Address: At+Post-Kamtaul, District-Darbhanga, Near-Bajrang Chowk, Bihar-

847304

Declaration:

Date: SincerelyPlace: Sumit Kumar