B SWATHI

Hyderabad

Contact: +91 9640315995/+91 7032364375

E-Mail: [email protected]

Objective:  To obtain a role as Drug safety associate in a progressive organization where I can maximize my Drug safety and Clinical research experience to achieve the project goals.

EXPERIENCE:

Aug 2012 – Aug 2013: JUNIOR DRUG SAFETY ASSOCIATE AT CLINCORP TECHNOLOGIES.

·        Receipt and processing of incoming safety information from multiple sources and requesting any additional information if needed, both internal and external to the company.

·        Collect, document, and evaluate adverse event information from any source using medical knowledge, experience.

·        Entry of relevant safety data into the ARGUS Global Safety Database from spontaneous sources, clinical trial cases, Post marketing surveillance and processing them. Possess knowledge about the literature cases.

·        Extensive work experience on Safety narrative writing, labelling, and assessment of seriousness, listedness, causality assessment of Adverse Events.

·        Worked on Argus safety system for management of adverse events, serious adverse events that occur with the investigational and marketed products.

·        Coding adverse events, suspect products and concomitant products using MedDRA and other company dictionaries within defined reporting timelines.

·        Confirmation of previously entered data and completion of data entry, including writing adverse event case narrative.

·        Review of Adverse event and Serious Adverse Event reports for accuracy, completeness, and consistency.

·        Utilized Oracle Argus Safety Database to log, track, prioritize, and to respond to product complaints and serious adverse events.

·        Assist in the quality review of data captured in the Argus safety system.

·        Possess knowledge about the MHRA and the yellow card regulations.

April 2011 – Aug 2012: ASSOCIATE RESEARCH ANALYST, THOMSON REUTERS.

·        Analysis and research of the clinical data and the patent information.

·        Performed medical coding of the events using MedDRA and coding the pharmaceutical drugs using WHODD.

·        Drawing of the structures of chemical compounds using ISIS Draw.

·        Extracting the information regarding the therapeutic activities of the drug and providing the information to the pharmaceutical organizations.

·        Translation of the patents mentioned in different languages and Searching of patents in WIPO, ESPACENET etc.

September 2010 – April 2011: CUSTOMER SERVICE ASSOCIATE, AMAZON.

·        Resolving of the queries of the Amazon customers through email on the Kindle (e-reader) device.

September 2009 – October 2009 : PROJECT – ASTRIX LABORATORIES.

·        Project work done on the preparation of an Active Pharmaceutical Ingredient in the Anti Cancer Drug in the Research and Development lab. Involves the Quality control and checking the API for the impurities using various quality control techniques.

July 2009 – Aug 2009 : INDUSTRIAL TRANING – SUVEN LIFE SCIENCES.

·        Industrial training on the equipment like the HPLC, GC, spectroscopy in the quality control department.

CERTIFICATIONS:

·        Certification in Pharmacovigilance.

·        Certification in Lean Six Sigma.

ACCOMPLISHMENTS:

·        Secured Band 7.5 in ILETS.

·        Awarded as Star Performer at Thomson Reuters.

·        Registered Pharmacist.

EDUCATION:

September 2010  – September 2012: Master of Business Administration in Health Care services  – B Grade.

June 2005 – Oct 2009: BACHELOR OF PHARMACY – 77% – First class with Distinction.

June 2003 –  June 2005: INTERMEDIATE BI.P.C – 94% – First class with Distinction.

TECHNICAL SKILLS:

·        Database: Oracle Argus Safety Database.

·        Dictionary: MedDRA & WHO Drug dictionary.

·         Applications: MS Office Suite.