Quality Assurance Control

CURRICULUM VITAE

SWATHI KASULA

W/o. SRIKANTH CHINTHAKUNTA

MOULALI

HYDERABAD

ANDHRA PRADESH, INDIA.

Contact no: +918*********

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

CAREER OBJECTIVE

Aiming to reach peaks and apply my skills in the field of pharmaceutical industry and to become a part of the organization that would give me an opportunity to expand my skills with latest trends and work dynamically towards the growth of the organization.

WORK EXIPERENCE

Worked as a Researcher in Product Profiles-MedTRACK, Excellence Data Research Pvt. Ltd. (A Division of Datamonitor Ltd), Hyderbad, INDIA. From July 2010 – May2011.

Skills Summary

Secondary Research

Therapeutic area analysis

Scientific writing Clinical Trial Analysis

Competitive Analysis

Datamining Pipeline Analysis

Database management

Pipeline Profiling: To collect and analyze the information about marketed and development stage products of Bio-Pharmaceutical companies including Product information, Clinical trial data, Drug delivery technology, Geography & market territory data, Regulatory information (Approvals & Filings of NDA, BLA, MAA etc), press release analysis & tracking, Deal for products and companies from various secondary sources like Company websites, Regulatory sites, Clinicaltrials.gov, SEC filings, Annual Reports, Scientific Journals (PubMed and Scirus) and healthcare conferences.

Competitive Analysis: Competitors study in a territory for a particular indication according to companies’ product pipelines using various available secondary resources.

Therapeutic area analysis: To analyze the pipeline products by targeting particular therapeutic area using various available secondary resources.

Trend Analysis: To perform the product life cycle analysis and graphically present product trend in Companies Product Portfolio.

Resolving and responding to internal and external queries related to product information from the client.

Working as a Health Care Professional Associate (HCPA) in Pharmacovigilance, Mahindra Satyam, Hyderabad, INDIA. From May192011 to till date.

Current Job Profile in Pharmacovigilance:

Completion of data entry from source documents including a narrative, complete the custodial review, detailing the adverse events, selection and coding of event terms, concomitant medications and medical history against the source document updates in Argus data and validation.

Review of source documents such as physician office records, hospital records and lab details for the cases received from legal offices/and their agents.

Evaluates consistency, completeness, accuracy of safety database, tracking database and source document entry forms.

Track, identify and compile market/competitor information on pharmaceutical, health and life science domains gathering pipeline data from various sources such as SEC-Filings.

Handling submission of ICSRs and other reports for various regulatory authorities across the globe.

Safety narrative writing for all reports that meet potential expedited reporting requirements like 15 NDA, CIOMS, PSURS with relevant CIOMS forms is forwarded electronically to regulatory authorities.

Supports the generation of Annual Safety Updates, Periodic Safety Reports and other cumulative safety reports including data retrieval, analyses and quality control.

AEM form completion from the source documents, including the patient details, suspect drug information, ADR’S, diagnosis and related details

Selection and coding of event terms using MedDRA browser.

Safety narrative writing of Non interventional study reports, Marketing Programs, Legal documents which includes claim letters, summons and complaints, plaintiff’s fact sheet and medical records.

Reconcile SAE’s in accordance with project specific guidelines.

Therapeutic areas of work included pain and inflammation, cardiovascular, urology and sexual health, psychiatry and mental health system, neuroscience, social medicines, hormonal, pulmonary system, diabetes, infectious disease(s) and cancers (oncology) etc.

Possess complete hands on knowledge in medical terminology, ICH-GCP guidelines, clinical research, FDA regulations (21CFR Part11), pharmacovigilance (adverse event reporting).

Well versed with applications like DIDE, Argus, GDMS, MedDRA and WHO browsers.

Hands on experience in framing narratives in consistency with source documents and according to the templates assigned.

Trainings Received:

Instructor led trainings of Argus.

Web based trainings of Argus and pharmacovigilance.

Received training on narrative writing

Database/ Tools:

ARGUS

S3

GDMS

MedDRA

Testing tools

ACADEMIC PROFILE

M. Pharmacy with an aggregate of 80 % from Teegala Ram Reddy College of Pharmacy, JNTU, Hyderabad.

B. Pharmacy with an aggregate of 75 % from Teegala Ram Reddy College of Pharmacy, JNTU, Hyderabad.

D. Pharmacy with an aggregate of 77 % from Raghavendra Institute of Pharmaceutical Sciences and Research, Anantapur.

Intermediate with an aggregate of 87 % from Vishwateja Junior College, Gajwel.

S.S.C completed with 72 % from ST. Joseph’s High School, Gajwel.

AREA OF INTEREST

Pharmacovigilance, Clinical Trials, Bioavailability & Bioequivalence Study

Regulatory Affairs

Quality Assurance

STRENGTHS

• Dedication and full commitment towards assigned tasks

• Problem solving attitude and team work

• Positive thinking and adaptability to new environment very easily

PERSONAL DETAILS

• Date of Birth : 12.09.1984

• Nationality : Indian

• Sex : Female

• Marital status : Married

• Languages Known : English, Hindi, and Telugu.

DECLARATION

I vouch the authenticity of the above-mentioned information.

Place: Hyderabad

Date:

(Swathi Kasula)

Contact this candidate