SHAIK.NAJMA
Email id : snajma325 AT gmail.com
CAREER OBJECTIVE :
To be associated with a progressive organization that gives scope to apply my knowledge and skills and to be a part of the team that dynamically works towards the growth of the organization.
ACADEMIC CREDENTIALS :
B.PHARMACY ANNAMACHARYA COLLEGE OF PAHRAMCY,KADAPA JNTUA 85
PROJECTS :
Under Graduation :
“PRELIMINARY STUDIES ON WATER ANALYSIS AND RELATED HEALTH RISKS IN THE PEOPLE OF RAJAMPET RURAL AREA”.
PROFESSIONAL CAREER
Drug Safety Associate(ICSR-Pharmacovigilance) from 21-Jan-2019 (currently in notice period), at Vigilare Biopharma Pvt ltd. Kukatpally, Hyderabad.
Roles and Responsibilities :
** Responsible for case intake, duplicate check.
** Responsible for data entry of individual case safety reports into 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.
** 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).
Individual case safety report department (ICSR) :
** Practical hands on experience regarding Case Processing on Oracle Argus Safety 8.1.2 including initial Case entry, Duplicity check and complete case entries.
** Assessment of case reports for seriousness and expeditedness.
** Narrative writing for initial and follow up reports.
** Quality check for processed cases.
** Knowledge Case report forms (CRFs), expedited and aggregate reporting.
** Understanding and knowledge on signal detection.
PROFESSIONAL KNOWLEDGE :
** Extensive know
ledge on Drug Safety and Drug Development.
** Sound knowledge on International Conference on Harmonization and Good Clinical Practices.
** Good Understanding of Clinical research and Pharmacovigilance and Regulatory affairs.
** KnowledgeofPatientcounselingandADRmonitoring.
PROFESSIONAL ACHIEVEMENT :
Received highest percentage in quality for processed Individual Case Safety Reports (ICSRs) in the all months from joining (99.7%) and got appreciation from the management.
TECHNICAL SKILLS :
Database : Oracle Argus Safety Database 8.1.2
Office Tools : MS Word, Excel, Power Point.
Operating System : Windows-8, Windows 10.
Dictionary : MedDRA 23.1; WHO Drug.
CERTIFICATION :
** NIDA clinical trials network certification of completion (Good clinical practice).
** Completed ICH Good Clinical Practice E6 (R2) certification from Global Health Training Center.
** Completed Introduction to Collecting And Reporting Adverse Events in Clinical Research from Global Health Training Center.
** Completed signal detection and causality assessment certification of UMC.
** Completed a six-month certification course of PG Diploma in Clinical Research and Pharmacovigilance from Stansys Software Solutions.
STRENGTHS :
** Good communication and presentation skills.
** Ability to give qualitative out-put with presenting and manages with the workload.
** Able to impart good working environment with good working moral ethics.
** Highly self motivated, results achiever, meeting deadlines.
** Good analytical thinking and decision-making ability.
PERSONAL DETAILS :
Date of Birth : 18th Jan
Father’s Name : Shaik.mabu sharieef
Languages Known : English, Hindi, Telugu.
DECLARATION :
I hereby declare that the information furnished above is true to the best of my knowledge.
DATE :
PLACE :