Data Entry

CURRICULUM VITAE

Bhupendra k. Sharma

Room no:- 368, S.M. Road,Sangam Nagar,

Wadala (East),

Mumbai- 400037.

Mobile- +918*********

Email id: ***********@*****.***

Objective

Looking forward for a career that offers challenge, high degree of resp onsibility, varying

exposure, scope for innovation and opportunity to learn and enhance my skills in the field of

clinical research.

Work Experience:

Summary: I have Post Graduate Diploma in Clinical research and graduated with

B.Pharmacy from Mumbai University. I have around 4 years of experience in

Pharmacovigilance and worked on both Arisg and Argus safety databases. I started my career

as Drug safety associate on contract basis (third party payroll) in Cognizant from May 2011-

Dec 2011 after which I worked in Tata Consultancy Services for 2.4 years as ICSR case

processor (1 year) and also as a Trainer (1.4 years). I am currently spearheading with

Cognizant as Quality Reviewer since April 2014.

Job Description

Name of the organization: Cognizant

Industry: Life sciences

Department: Pharmacovigilance

Total Tenure: Apr2014-till present

Work profile: Case processing and Quality review

Designation: Data Analyst

Search the safety database for duplicate reports.

Evaluate case information for Medical Completeness.

Each reported adverse event within a case is evaluated for potential up gradation for

seriousness. Medical judgment is advised in deciding whether an upgrade is

appropriate and the upgrade is documented.

Code the following fields using the most appropriate Lower Level Term (LLT) from

MedDRA:

- Medical history

- Reported AEs,

- Other reported safety information,

E.g. medication error, pregnancy etc.

- indication for use of suspect and

concomitant medications

- labs and procedures

- cause(s) of death

- Assess Expectedness

Create and update case narrative

Review the case and give feedback.

Job Description

Name of the organization: TATA Consultancy Services.

Industry: Life sciences

Department: Pharmacovigilance

Total Tenure: Jan2012-Apr2014

Work profile: Pharmacovigilance scientist level-I (Jan 2012-Dec2012)

Pharmacovigilance scientist level-II (Mentor) (Jan 2013-Apr2014)

Designation: Drug safety associate (Jan 2012- Apr 2014).

Pharmacovigilance scientist level-I Responsibilities: (Jan 2012-Dec2012)

Accountable for handling ICSRs received via data exchange systems,

disposition of valid items into ARISg from IRT for further processing in

ARISg.

Accountable for performing accurate data capture for individual case safety

reports which can be spontaneous, clinical, or NIS origin.

Accountable for sending queries for clarity associated with incoming

information if required.

Handling invalid items in IRT appropriately through reference to SOPs,

relevant training and the ARISg user manual.

Accountable for performing the appropriate clinical assessments (including the

assessment of seriousness, labeling and company causality for each adverse

event) adhering to SOPs/other controlled documents and regulatory

requirements.

Responsible for identifying duplicate/invalid ICSRs in ARISg and handling as

per relevant SOP.

Pharmacovigilance scientist level-IIResponsibilities:

Assisting Client in the development and implementation of Drug Safety Standard

Operating Procedures, training material and other associated documents.

Responsible for identifying and implementing continuous improvement activities.

Accountable for establishing and implementing best practices sharing in

Pharmacovigilance activities.

Assisting in relevant Drug Safety projects and taking ownership for assigned

processes and projects (as needed).

Providing training to new staff. To include tasks such as:

o Guiding and mentoring new associates on Drug Safety activities relating to

ICSR processing as defined in Pharmacovigilance Scientist Level I Job

Description

o Effective delivery of training modules

o At Client’s request, developing training modules for Client approval to use for

training purposes

o Proactively providing feedback about incomplete, inaccurate or missing

training material to Client

o Identifying ongoing areas for improvement in the training process

o Identifying lack of understanding of individuals in training sessions and

address identified needs

o Discussing associates understanding of training delivered with mentors and

managers as required

o Responsible for providing guidance and support to new mentors/trainers

o Ensuring sign off documentation is in place and accurately reflects the

individuals training

o Resolving queries, identifying areas of concern, ensuring that outstanding

training needs are addressed and timely feedback is provided for associates in

mentoring

o Maintaining mentoring spreadsheets (as applicable) for each associate through

to sign off approval

o Sharing mentoring spreadsheet with Client when requested to allow discussion

of each associate in mentoring

o Conducting and facilitating the sign off review meetings

o Ensuring that the associate maintains up to date training records during their

mentoring period

Assisting Client in preparation, delivery and maintenance of training programs

Performing Quality Review for Drug Safety (as appropriate). To include such tasks

as:

o Accountable for in line quality review of ICSRs processed based on pre-

agreed volumes and case inclusion criteria

o Providing feedback on errors to individual associates as necessary

o Identifying refresher training required by associates and highlight training

needs or QR trends to Drug Safety Management at TCS

o Participating in quality and compliance meetings as required

Job Description

Name of the organization: Cognizant (On contract basis-third party payroll)

Industry: Life sciences

Department: Pharmacovigilance

Total Tenure: Apr2011-Dec2011

Work profile: Data migration Data entry Associate (May 2011- Dec2011)

Designation: Business Associate (Apr2011-Dec2011)

Data Migration Data Entry Responsibilities:

1. Log onto client’s corporate safety database, e.g. Argus.

2. Book-In cases received from Data Migration Share Point, perform a duplicate

search, book the case into the client’s corporate safety database, e.g. Argus,

and attach the Source Document to the case and then route the case for data

entry

3. Complete “heads down” entry of the data contained within the source

documents in accordance with the appropriate mapping documents.

4. Upon completion of data entry, Cognizant will add a note in the Contact Log

indicating data entry was completed and save the case.

5. Upon completion of data verification, Cognizant will route the case back as

appropriate, utilizing the appropriate workflow state in client’s corporate

safety database, e.g. Argus.

Company: NEXUS CRO. (Oct2010-Dec2010)

Position: Clinical Research Co-ordinator.

Job profile: Phase III trial on Acute Musculoskeletal Spasm.

Safety and Efficacy of the drug.

Patient monitoring and follow up.

Filling of Case Report Form and IC and other records.

Phase III trial on Acute Idiopathic Constipation.

Safety and Efficacy of the drug.

Patient monitoring and follow up.

Clinical Data Management

Company: THE PHARMACEUTICAL PRODUCTS OF INDIA LTD.

Position: Trainee in Production and Quality control.

Job profile: Assisted in formulation of granules.

Educational Qualification:

Board/

Sr

Qualification School/College University

no.

Diploma in clinical

1 NEXUS NEXUS

research

N.C.R.D’s Sterling Institute of Mumbai

2 FINAL YEAR University

Pharmacy

N.C.R.D’s Sterling Institute of Mumbai

3 T.Y.BPharm University

Pharmacy

N.C.R.D’s Sterling Institute of Mumbai

4 S.Y.BPharm

University

Pharmacy

Mumbai

N.C.R.D’s Sterling Institute of

5 F.Y.BPharm University

Pharmacy

Maharashtra

6 H.S.C S.I.W.S college

Board

Maharashtra

7 S.S.C SitaramprakashHigh School

Board

COMPUTER PROFICIENCY:

Well versed with windows based environment.

MS Office, (MS –word, MS –excel, MS-power point) access.

Well versed with internet and referencing using the same

Project:

1. Arthritis

2. Clinical trials on eperisone + diclofenac.

3. Clinical trials on Isapgul.

Extra Curricular Activity:

I. Participated in the 60th Indian Pharmaceutical Congress as a delegate, Delhi 2008.

II. Blood donation camp.

III. Attended seminar on Entrepreneurship.

ACHIEVEMENTS:

Awarded with TCSgems for excellent performance.

Personal Dossier:

04th January,1986

Date of birth:

Sex: Male

Nationality: Indian

Religion: Hindu

Languages Known: English, Hindi, Marathi,

Hobbies: Listening music.

Current CTC 4.6 lacs per annum

Expected CTC negotiable

Current designation Data Analyst

Notice Period 2 month

Declaration:

I hereby affirm that the above-mentioned details are true and correct.

DATE: SIGNATURE:

PLACE: Mumbai Bhupendra K. Sharma.

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