B SWATHI

Hyderabad, India

Contact: +91-964*******

E-Mail: ad14op@r.postjobfree.com

Objective: To obtain a suitable role in a progressive organization where I can utilize and maximize my work experience to achieve the project goals. WORK EXPERIENCE:

5 September 2022 – 2 AUGUST 2023: SENIOR ASSOCIATE – MEDICAL/CLINICAL RESEARCH, VIRTUAL EMPLOYEE PVT LTD

Directly working for the client “Related Sciences” based in Denver, the United States.

Primary, secondary research and analysis of market approved and pipeline drugs in the United States.

Complete data analysis and data sorting for the client to understand the potential of already available drugs in market in comparison with the drugs undergoing clinical trials. In vitro and In vivo analysis.

Comparison of the drug data from clinicaltrials.gov with Institute for Clinical and Economic Review (“ICER”) data.

Working on clinical databases like Informa, Pharma Projects, Trial trove and extracting data in the client required format.

Extensive secondary research on clinical trials.gov and package inserts (Daily Med) to understand the efficacy of the approved drugs in the United States.

Understanding the black box warning as per categories and using it in the secondary research and analysis.

Extraction of the efficacy and serious adverse events of the interventional drug and comparator, analysis of primary and secondary endpoints, dosages and combinations from clinical trials.gov.

Preparation of PowerPoint presentations and representation of data in the form of charts to present to the stake holders.

Citeline mapping, Research on the Experimental Factor Ontology (“EFO”) website to identify the correct Ontologies of the diseases and the sub categories of the diseases in project.

Ontology lookup service (“OLS”), mapping of the diseases in Trial trove with EFO, MONDO etc. ontologies which enables better comparison of drugs to take informed decisions.

Assisting the Company in taking informed decisions and strategic planning in the drug development and marketing processes.

Proficient in using slack for business communication. 5 April 2021 – 30 August 2022: ASSOCIATE, ALLIANTGROUP PVT LTD

Data analysis in excel using pivot tables, v lookup’s, fuzzy lookups. Extracting data from PDF’s using tools such as able2extract professional and analysing data using formulas in excel.

Drafting research and development reports involving pharmacy case studies.

Extensive secondary research and market research on pharmaceutical drugs and recent case studies and including all the valuable information in reports.

Involved in medical writing, report writing, content writing.

Involved in checking peer reports to minimize errors.

Giving feedbacks on regular basis to peers to achieve error free high quality reports.

Delivering the reports within the timelines and meeting the team SLA’s. 1 March 2021 – 22 September 2021: ASSOCIATE ANALYST, LARVOL

Extensive secondary research on drugs in oncology therapeutic area. Research on the mechanism of action, side effects, pharmacological action using competitive intelligence.

Secondary research on websites such as Lancet, European Society for Medical Oncology, British journal of cancer, Targeted oncology, Journal of immunotherapy of cancer, International journal of clinical oncology, clinicaltrials.gov, American Society of Clinical Oncology, American Association for Cancer Research, National Centre for Biotechnology Information, American Society of Haematology publications, Oncologist, International Association for the Study of Lung Cancer.

Good domain knowledge of all phases of clinical trials, assessment of primary and secondary end points of evaluation.

Digitization of straight and reverse Kaplan-Meier curves.

Extracting data from the Kaplan-Meier curves and representing the drug pharmacological action in various phases of trial in client understandable format.

Research and study of various endpoints like overall survival, progression free survival, disease free survival, metastasis free survival, pathological complete response, recurrence free survival, relapse free survival, duration of response, event free survival, time to tumour progression, time to treatment failure.

Research on best overall response, clinical benefit rate, disease control rate, objective response rate, health related quality of life of various cancer drugs in all phases of clinical trials.

Analysis of tumour shrinkage, tumour size, overall response of anti-cancer drugs in clinical trials.

Research on hazard ratios, P values in survival analysis to determine the potential of interventional drug.

Quality control of the work done by peers and delivering feedbacks on day-to-day basis to improve the quality of work.

Using SWOT analysis to identify the errors and design plan so that work can be done efficiently and error free.

Accepting adhoc tasks and completing them within deliverable timelines with high quality standards.

1 Dec 2020 – 31 Jan 2021: SUBJECT MATTER EXPERT, AMAZON

As a SME, managed a team of 8-10 members and trained them on how to approve or reject a prescription uploaded by the patient.

Multitasking almost all the time and made sure that there were no errors while multitasking.

Coached the team if they were any errors from their side by doing the Daily audits of the work done by the team.

Conducted one on one sessions to understand the challenges faced by associates individually.

Updated the process knowledge on daily basis by going through the updates if there are any and making them clear to the team.

Made sure that the team is working according to the SOP and ensuring that work is completed within SLA’s, checking if they are quality compliant and if there were any major deviations, planned performance improvement sessions for them.

Took debrief sessions to team to let them know the expectations on them.

Prepared daily summary report of team’s performance and shared with managers via email.

Logged in before the shift timing and prepared for the shift, brainstorming the ideas before addressing them to the team.

Worked on additional projects assigned by managers simultaneously in addition to assisting team.

Reached out to managers and informed them the situation, when there are major deviations in the working procedure by the team.

Assisted other teams as well when the other SME’s are on leave, etc. Able to manage and handle multiple people at a time and coach/ train them accordingly. Feb 2020 – Dec 2020: PHARMA ASSOCIATE, AMAZON

Accomplishing the day - day responsibilities in approving prescriptions or rejecting prescriptions which are uploaded by patients for purchasing medicines on Amazon.in

Worked following the standard operating procedures and assisted the patients as E- Pharmacist.

Always was good in maintaining the quality of the work and completing the work within the set deadlines.

Worked on the berry pharmacy tool which is a software used for the prescription approval/ rejection.

Played a key role in making the patient understand why the medicine was rejected and also the importance of approving correct medications as prescribed by the doctor.

A very active team player and contributed so much to the team performance by always raising the bar and maintaining highest quality standards.

Received appreciations from the top leadership as well for outstanding performance.

Within 10 months tenure was promoted as subject matter expert and I was given a team to coach / train them.

April 2011 – Aug 2013: ASSOCIATE RESEARCH ANALYST, THOMSON REUTERS

Receipt and processing of incoming Drug 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.

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

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

Extracting important pharmaceutical information from the patents by doing secondary research on patent websites like IPO, ESPO etc.

Storing all the secondary researched information in DWPI (Derwent world patent index) which is an exclusive product of Thomson Reuters, this product is purchased by the leading pharmaceutical companies to extract the patented information.

Involved in Manual coding, Indexing, ISIS Draw and representing the pharmaceutical components in the form of Markush.

September 2010 – April 2011: TECHNICAL SERVICE ASSOCIATE, AMAZON

Resolving of the queries of the Amazon customers through email. 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 Six Sigma Yellow Belt. (Awarded at Thomson Reuters)

Certification in Pharmacovigilance.

ACCOMPLISHMENTS:

Secured Band 7.5 in ILETS.

Awarded as Star Performer at Thomson Reuters.

Promoted as SME within 10 months in Amazon.

Registered Pharmacist.

EDUCATION:

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

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.

Contact this candidate