OBJECTIVE: To secure a Drug Safety Associate position that will

promote growth, stability and opportunity

for advancement.

EDUCATION: Trinitas School of Nursing, Elizabeth, NJ

NLN Designated Center of Excellence for Nursing Education

2008 - 2011

Registered Nurse Diploma, May 2011

Union County College, Cranford, NJ, Associate Degree in

Science, May 2011

CREDENTIALS: New Jersey Registered Nurse License No: 26NR15696200, May

22, 2011 - present

Certified as Registered Nurse Assessment Coordinator through

AANAC, July 2012 - present

Certified Drug Safety Associate through Q-Tech Solutions

Inc., Somerset, NJ - September 20, 2014

SUMMARY OF QUALIFICATIONS:

. Basic knowledge of drug development process, clinical trial process and

clinical development plans

. Extensive knowledge about medical and nursing practices and their

procedures

. Ability to work as part of a team while being independent

. Utilized the nursing process: assessed, diagnosed, planned, implemented,

and provided evaluation

. Excellent communication skills, both written and verbal

. Possess good leadership, problem solving and time management skills

. Excellent track record for optimization of Case Mix Index for Medicaid

reimbursement

. Proficient in all documentation/record maintenance to ensure accuracy and

HIPPA regulation

WORK EXPERIENCE:

Drug Safety Intern, August 2014 - present

Q-Tech Solutions Inc., Somerset, NJ

. Received and processed ICSRs from clinical trial and spontaneous reports

. Performed triage for seriousness, relatedness, and expectedness and

prioritized of incoming adverse events as per the protocol, investigator

brochure, and/or labeling

. Prioritized cases based on seriousness of adverse events in accordance

with SOP and regulatory guidelines

. Evaluated and extract relevant information from medical records in

accordance with US FDA safety regulations

. Entered data and relevant information from extracted medical records into

safety database screens in a word format

. Generated well written, concise and accurate narratives for both serious

and non-serious cases

. Assessed information for completeness, obtaining and adding required

information from local affiliates when necessary

. Promptly and accurately interpret and entered serious and non-serious

adverse events into the safety database

. Performed AE-SAE reconciliation

. Identified patient outcome and event type for medical device adverse

event cases

. Reviewed the SAE Reports Forms and determined and listed

discrepancies/queries found

MDS Coordinator (119 beds Skilled Nursing Facility), May 2013 - present

Princeton Care Center, 728 Bunn Drive, Princeton, NJ

. Working closely with Therapy Manager in setting Assessment Reference Date

(ARD) to maximize Medicare and Medicaid reimbursement

. Completing assessments, Minimum Data Set (MDS) and care plans for all

residents according to ARD

. Monitoring completion of MDSs by other disciplines within timeframes

prescribed by regulatory guidelines

. Initiating care plans and supporting activities that will result in best

possible outcome for assigned residents

. Generating and distributing monthly care plan calendar to the

Interdisciplinary Team

. Conducting care plan conferences with Interdisciplinary Team for assigned

residents

. Reviewing all resident incidents and accidents and the 24-hour report

daily to ensure that care plans for assigned residents reflect current

and changing needs

. Participating in facility management meetings

. Promoting and participating in ongoing education, inside and outside the

facility, to maintain and enhance knowledge of current / new regulations

. Generating Utilization Review (UR) worksheet and initiating weekly UR

meeting with management

Staff Nurse (sub acute and long term care), November 2011 - April 2013

Princeton Care Center, 728 Bunn Drive, Princeton, NJ

. Provided care to an average of 19 sub acute residents and 27 long term

care residents

. Acted as a resident advocate by addressing individual resident needs

. Managed the planning and implementation of interventions and coordinated

resident referrals and discharge planning activities

. Collaborated with Physicians, Physician Assistants, Physical and

Occupational Therapists, Social Worker, as well as resident's family

regarding care and needs

. Made observations and continuous assessments of resident's health status

through complete and accurate documentation

QUALIFICATIONS: Proficient in Microsoft Office (Word, Excel, Outlook,

PowerPoint), fluent in Gujarati and Hindi, detail oriented and possess

strong organizational skills

References Available

Contact this candidate