Clinical Research Pvt Ltd

VIKAS KUMAR

Address: House No- **A, Street no- *

Amar Colony, Kamruddin Nagar

Nangloi (New Delhi), Pin- 110041

Mobile No: +91-999*******

E mail: acqi3m@r.postjobfree.com

OBJECTIVE

To grow with the organization, take challenging assignments, make performance linked progressive career, and contribute in growth of the organization in field of pharmacovigilance and clinical research.

WORK EXPERIENCE

SCIFORMIX TECHNOLOGIES PVT LTD

Currently I have been working as Drug Safety Data Analyst with SCIFORMIX since Jan/2015. Before this, I worked as Junior Drug Safety Data Analyst with SCIFORMIX from Aug/2013 to Dec/2014.

SCIFORMIX JOB PROFILE:-

1.Peer review of spontaneous, consumer solicited, HCP solicited, regulatory, business partner, and literature cases.

2.Distribution of cases.

3.Provide client specific training, database training, and company products trainings to new joiners.

SYNOWLEDGE PV SERVICES INDIA PVT LTD

I worked as Drug Safety Associate (Quality Verifier) with SYNOWLEDGE from Dec/2012 to Aug/2013.

SYNOWLEDGE JOB PROFILE:-

Quality review and verification of ICSRs on ARGUS using MedDRA, Client conventions, and CDD/WHO DD with following responsibilities:

4.Duplicate case searching.

5.Matching consistency and accuracy of narrative and all entries in database with source documents.

6.Ensuring classification of case.

7.Ensuring coding of suspects, concomitant, treatment, and past medications.

8.Ensuring coding of events and their ranking.

9.Checking labeling of events in listing documents.

10.Ensuring appropriate assessment of validity, medical conformation, and seriousness of cases.

11.Generation of CIOM forms.

12.Matching consistency of source document with CIOM form.

WIPRO PVT LTD

I worked as Pharmacovigilance Officer (Book-In HCP) with WIPRO from Jan/2012 to Dec/2012.

WIPRO JOB PROFILE:-

Generation and Processing of ICSRs on Argus using MedDRA and CDD/WHO DD with following responsibilities:

1.Duplicate case searching.

2.Processing of serious/non-serious cases, device cases, vaccine cases, product complaint, at-risk cases, and invalid cases.

3.Selection of appropriate classification of case.

4.Checking of appropriate PR/PC/CC of reporters.

5.Coding of drugs (suspects/concomitants) using CDD and WHO DD respectively.

6.Coding of adverse events, medical histories, indications, and lab tests using MedDRA.

7.Ensuring correct sequence of adverse events and drugs.

8.Assessing validity, medical conformation, and seriousness of cases.

9.Populating appropriate dechallenge and rechallenge.

10.Follow-up with primary physician and reporter as per information provided.

11.Generating appropriate action item/letter as per required timelines.

12.Generating other company notification as per required timelines.

13.Generating CIOMS forms.

14.Generating appropriate HCP letter or Non-HCP action item for further f/up.

15.Writing Contact Log.

16.Attachment of required DCA in HCP follow-up letter.

17.To judge if follow-up is medically significant or not.

PROJECT TRAINING

I completed project on pharmacokinetic and pharmacodynamics effects of drugs from FORTIS CLINICAL RESEARCH PVT LTD in 2010.

EDUCATIONAL QUALIFICATIONS

1.B. Pharmacy from Maharshi Dayanand University (Haryana) with 69% in 2010.

2.P.G D in Clinical Research from Catalyst Clinical Services with 80% in 2011.

SKILLS AND STREANGTHS

1.Working knowledge of software ARGUS (FDA approved database for drug safety).

2.Good communication and computer (MS office) skills.

3.Ability to work with minimal supervision.

4.Enthusiastic, flexible, optimistic, and quick to learn.

5.Have high sense of responsibility and believe in “It pays to smart and strive hard”. "I can fit the bill".

PERSONAL DETAILS

Date of Birth : 26 Nov1987

Father’s Name : Mr. Vijay Bansaal

Gender : Male

Marital Status : Single

Nationality : Indian

Hobby : Doing meditation, swimming, and reading health magazines etc.

Language Known : English and Hindi.

Current Address : Andheri (E) Mumbai

I hereby declare that all the information mentioned above is true to the best of my knowledge, efforts, and belief.

Date

Place VIKAS KUMAR

Contact this candidate