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Drug Safety Associate Resume Sample, Experience : 2 years



Name of the Candidate:[Private]
Name of the Post Applied:Drug Safety Associate
Job related skills / software:Review ICSR, Responsible for case intake, duplicate check, and registration, Maintain log of source documents and other communications
Sub Category:Pharmacovigilance
Years of Experience:2 years
Salary Expected per Month(Rs):30,000 to 40,000
Highest Qualification attained:M. Pharmacy
Major / Specialization:Pharmacology
Email Id:[Private]
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
Sponsored Links:

Resume Format / CV Sample Template / Example / Model :


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 communications

As 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 narrative

As 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.
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- 4434

M.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 7
Office 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.Soumya
Date of Birth  :16-03-1989
Age  :26 Yrs
Marital status  : Married
Languages conversant  : Telugu, Hindi, English, Kannada

Declaration :
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 :
Place :


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