Senior Drug Safety Associate

RESUME

M N Chowdary. Nandipati

Sri sai homes apartment

Flat no;104, vijaypuri- 6lane

JKC College Road, Guntur – 522006

Andhra Pradesh. Mobile No: +91-970*******.

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

Kindly contact between :4 pm – 9 pm

CAREER OBJECTIVE:

To secure a challenging position as a professional with a progressive

organization where success is driven and prioritized through personal

development and team work.

Professional experience:

Sound knowledge in handling of IRT, ARISg and drug safety regulatory obligations.

Good experience in handling and processing ICSRs of spontaneous, clinical (day 15/7

SUSAR), NIS and NIP origin.

Good knowledge of medical terminology, ability to write clear, concise and unambiguous

medical text.

Company Name: TATA CONSULTANCY SERVICES

About the company:

TATA Consultancy Services Limited (TCSL) is a multinational information technology (IT)

service, consulting and business solutions company headquartered in India. TCS operates in 46

countries. It is a subsidiary of the TATA Group and is listed on the Bombay Stock Exchange and

the National Stock Exchange of India. TCS is the largest Indian company by market

capitalization and is the largest India-based IT services company by 2013 revenues. TCS is now

placed among the ‘Big 4’ most valuable IT services brands worldwide. In 2013, TCS is ranked

40th overall in the Forbes World's Most Innovative Companies ranking, making it both the

highest-ranked IT services company and the top Indian company. It is the world's 10th largest IT

services provider, measured by revenues.

Designation: Pharmacovigilance scientist level I

Duration: Since 28/Jan/2014 to till date

Job description:

Responsible for handling ICSR files received via data exchange systems, diposition of

valid items to ARISg from IRT for further case processing in ARISg and acknowledging

receipt of ICSRs to sender.

Accountable for sending queries for clarity associated with incoming information based

on requirement.

Handling of duplicate/invalid items in IRT, ARISg and handling as per reference to

SOPs.

Accountable for performing the appropriate clinical assessments and accurate data

capture for individual case safety reports of spontaneous, clinical, NIS and NIP in origin.

Responsible for identifying duplicate or invalid ICSRs in ARISg.

Assisting in clinical trial reconciliation process, a well reconciliation activities associated

with safety data exchange and pharmacovigilance agreements.

Assuring compliance with client database through reference of latest SOPs and relevant

manuals.

Assuring and maintaining compliance with regulatory and local/global SOP timelines

using proactive work flow management.

Representing drug safety in regulatory inspections and audits as required.

Developing and maintaining knowledge of the appropriate disease biology areas and

associated client product knowledge.

Responsible for developing a collaboration with relevant drug safety personnel for

maintaining awareness of critical adverse events, knowledge of labeling documents and

other issues of client products.

PERSONAL SKILLS:

1Sincere, Hardworking, Organized and Systematic.

2Positive approach and excellent verbal and written communication skills

3Comprehensive problem solving abilities, willingness to learn

4Leadership qualities, Ability to deal with people diplomatically, team facilitator.

5Good grasping of medical terminology, anatomy and physiology, systems and

disease processes, as well as managed care, emerging medications, inventory

management and regulations governing pharmacy services.

EDUCATIONAL QUALIFICATION

1. Completed MBA (HRM) in ACHARYA NAGARJUNA UNIVERSITY CENTER

FOR DISTANCE EDUCATION, Guntur, 2014 passed out.

2. Completed M-pharmacy (Pharmacology) in Hindu college of pharmacy, Guntur

2014 Passed out with an aggregate of 80.33%.

3. Bachelor of Pharmacy (BPharmacy 2010) from Sarada College of Pharmaceutical

Sciences, Narsaraopet, Guntur (dist.)Andhra Pradesh with 74% aggregate affiliated

to ACHARYA NAGARJUNA UNIVERSITY

4. Board of Intermediate Education (Bi.P.C) from Vikas Junior College, Guntur

with 81% (2004-2006).

4. School of Secondary Education (S.S.C) from GSR Model School, Guntur,

Andhra Pradesh with 79 % (2003-2004).

National & state level exams qualified:

Qualified GPAT(ALL INDIA EXAM FOR PG ADMISSION )-2011

SECURED ALL INDIA RANK; 1634. (Hall ticket no; 9012263).

Qualified GIPAT 2011-PG, secured RANK; 31, conducted by GITAM

UNIVERSITY.

Qualified Pgecet 2011 conducted by APSCHE,SECURED RANK;394 (SATE

LEVEL EXAM)

WORK SHOPS AND CONFERENCES

Attended international conference on Need for the introduction of Regulatory

Affairs in Pharmacy Curriculum, JNTU Hyderabad.

Participated in “National Workshop on Opportunities in Clinical Research for

Pharmacy and Biotechnology” organized by Vignan Pharmacy College and

Configer Bio Pharma Services, Guntur.

TECHNICAL QUALIFICATION

1. OS; XP, VISTA, WINDOWS7 & 8, MAC, Linux.

2. Good knowledge and understanding of

a) GCP and GLP guidelines.

b) ICH guidelines of safety, efficacy, quality.

c) Toxicity testing guidelines as per OECD, WHO guidelines.

3. Proficient with scientific data extraction and management.

4. Knowledge of computer software’s like MS-Office Suite, Graph Pad Prism, sigmaplot.

5. Handling of UV & Visible spectroscopy, laminar air flow unit.

6. Animal handling (wister & albino rats, BALBc Nude mice)

7. Handling of Y-MAZE equipment.

8. Handling of SEMI AUTO-ANALYSER.

Publication:

Published a Research Article on “ANTITUMOR ACTIVITY OF MIMOSA RUBICAULIS lam

AGAINST EHRLICH ASCITES CARCINOMA IN SWISS ALBINO MICE” in International

Journal of Pharmaceutical Sciences and Research. IJPSR, 2014; Vol. 5(4): 1514-1524. As

corresponding author.

http://www.ijpsr.com/V5I4/52%20Vol.%205,%20Issue%204,%20April%202014,%20IJPSR,

%20RA-3324,%20Paper%2052.pdf

M.phramacy Academic Project Details:

Title;

ANTITUMOR ACTIVITY OF MIMOSA RUBECAULIS lam AGAINST

EHRLICH ASCITES CARCINOMA IN SWISS ALBINO MICE.

Description;

The antitumor activity of the methanol stem extract of Mimosa rubicaulis lam

(MEMR) was evaluated against Ehrlich Ascites Carcinoma (EAC) tumor model in Swiss

albino mice. After 24h of intraperitonial inoculation of tumor (EAC) cells in mice,

MEMR was administered at the dose of 100, 200 and 400mg per kg body weight orally

for 13 consecutive days. After 24 h of the last dose and followed by eighteen hours of

fasting, mice were sacrificed and antitumor effect of MEMR extract on EAC bearing

mice was assessed by evaluating tumor volume, viable and nonviable tumor cell count,

mean survival time, percentage of increase in life span and hematological parameters of

EAC bearing host. MEMR showed significant (p< 0.0001) decrease in tumor volume,

viable cell count, percentage of increase in life span of EAC bearing mice.

Haematological profile such as RBC, WBC, Haemoglobin, PCV (packed cell volume)

levels restored to more or less normal level in MEMR treated mice as compared to EAC

control. Effect of MEMR on viability (cytotoxic effect) of cancer cell lines (such as EAC,

MCF-7, MDA-MB 435S) was evaluated by XTT assay, MEMR exhibited significant

effect on cell viability. Therefore, from the results of the present study it can be

concluded that MEMR exhibited significant anti tumor activity against Ehrlich ascites

carcinoma (EAC) in Swiss albino mice. The XTT assay and DNA laddering results

indicate that MEMR exhibited cytotoxic effect on EAC, MCF-7, MDA-MB 435S cell

lines and induced Apoptosis in EAC cell line.

Key words: Mimosa rubicaulis, Ehrlich Ascites Carcinoma, 5-fluorouracil, MCF-7,

MDA-MB 435S.

Conclusion;

Based on invivo results it can be concluded that the life span of EAC tumor

bearing mice was increased which is a reliable criteria for judging the value of anti cancer

drug, based on invitro results it can be concluded MEMR exhibited cytotoxic effect

against cancer cell lines and based on DNA laddering assay it can be concluded that

MEMR induced apoptosis in EAC cells. It is valuable for further investigation including

elucidation of active components responsible for anti tumor activity.

B.pharmacy Project details

Title:

Anti Microbial investigation on the root and stem extracts of MimosaRubicaulis

Lam

Since very little research work carried out on Mimosa Rubicaulis, we selected the plant

for Investigating anti microbial activity of its root and stem extracts.

Collection of Plant: kotappakonda hill region, Narasaraopet, Guntur, A.P, INDIA.

Its identity was confirmed by DR.M.Venkaiah, associate professor, Department of

botany, University College of sciences and technology ANDHRA UNIVERSITY,

Vishakapatnam.

Test Organisms used:

The cultures are obtained from National collection of Micro Organisms, Pune.

Gram-positive organisms: Bacillus subtilis, Bacillus pumilis

Gram-negative organisms: Escherichia coli.

Method used for the study; cup and plate method.

Conclusion:

Mimosa rubicaulis root extract exhibited good antimicrobial activity.

PERSONAL DETAILS

Father’s Name : Hanumantha Rao. N

Date of Birth : 15th July 1988.

Mother Tongue : Telugu

Languages known : English, Hindi and Telugu

Nationality : Indian

Marital Status : Unmarried

Gender : Male

Permanent Address : sri sai homes apartment,

Flat no 104,vijaypuri 6 lane,

Jkc college road, Guntur.

DECLARATION

I hereby declare that the information furnished is true to the best of my knowledge.

Place:

Date: M N Chowdary. Nandipati.

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