Career Objective :
By acquiring knowledge, expertise and familiarity with the organization’s culture that enables me to develop myself as a professional, I want to contribute my skills and expertise towards the growth of the organization.Summary of Skills :
** Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.
** In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines.
** Skilled in technical and general communication.
Good leadership, analytical, problem-solving and time management skills.Work Experience :
Synowledge India Pvt. Ltd. Mysore,Drug safety associate (Mar2014 to present) :Essential duties and responsibilities :As Case Intake Member :
** Responsible for case intake, duplicate check, and registration
** Maintain log of source documents and other communicationsAs Case Processor :
** Responsible for data entry of individual case safety reports into the safety database.
** Review and evaluate AE case information to determine required action based on and following internal policies and procedures
** Process all incoming cases in order to meet timelines
** Full data entry including medical coding and safety narrativeAs Medical Coder :
Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)As Narrative Writer :
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.As Literature Review Specialist :
** Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
** Review of literature articles to identify case safety reports.
** Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
** Assist in signal generation and safety analysis activities.
** Ensure quality of literature searches and reporting.
** Review of local/global literature reports to determine regional reportability.
** Create/maintain study summary documents.
** Assist with narrative writing for periodic/ad hoc submissions.
** Assist with ad hoc or routine safety monitoring activities.Other responsibilities :
** Following up with sites regarding outstanding queries.
** Follow up on reconciliation of discrepancies.
** Follow departmental AE workflow procedures
** Closure and deletion of cases
** Perform any other drug safety related activities as assigned
** Perform literature review activities when trained and assigned.Educational Qualifications :
** M.Pharmacy (Pharmacology) Malla Reddy Institute of Pharmaceutical Sciences, Hyderabad JNTU 2014 80%
** B.Pharmacy Learners Land College Of Pharmacy, Warangal JNTU 2011 75.65%
** Board of Intermediate Krishnaveni College, Kothagudem, Khammam dist. Sponsored links :
Board of intermediate education,A.P 2006 90%
** Secondary School Education Triveni School, Kothagudem, Khammam dist. Board of secondary education,A.P 2004 91.5 %
*Qualified in GPAT (2011), All India Rank- 4434M.Pharmacy project :
Evaluation of Anti-diabetic and Anti-oxidant activity of Actinodaphne madraspatana leaves in Alloxan induced diabetic rats.Industrial Exposure :
** Undergone industrial training from SK Health Care Formulations Pvt. Ltd., Bachupally (v), R.R. Dist. Hyderabad.
** Acquired basic knowledge in Quality Control, Quality Assurance & Production departments.Computer proficiency :Databases : Diploma in Computer Applications (DCA)Operating environments : Windows 98/2000 XP & Windows 7Office tools : Microsoft Office (Word, Excel, Power point)
Well versed with Internet.Accomplishments :
Licensed Pharmacist in Andhra Pradesh Pharmacy council of India (APPCI : 85511/A1).
** Completed Professional Diploma in Clinical Research (PDCR) program from Catalyst Clinical Services Pvt. Ltd. New Delhi.
** Good understanding of clinical research Process- Phase I to IV.
** Good understanding of the Clinical Study Protocol. Participated national seminar:
** Current trends in pharmacy education and industry by Dhanvanthari institute of pharmaceutical sciences (DIPS), Kothagudem, Khammam dist.
** Preparing pharmacists for the global challenges and emerging opportunities in Clinical Research and Novel Drug Delivery Systems by MRIPS, Hyd.Publications :
Pharmacological Evaluation for Anti-depressant activity of Vanda spathulata in mice; International Journals of Pharma and biosciences; 2013 July; 4(3) : (P) 866 – 872.Personal Information :Name : B.R.SoumyaDate of Birth :16-03-1989Age :26 YrsMarital status : MarriedLanguages conversant : Telugu, Hindi, English, KannadaDeclaration :
I, hereby declare that the above furnished information is authentic to the best of my knowledge and belief and nothing has been concealed here in.Date :
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