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Click here or scroll down to respond to this candidate Chandni Singla
https://LINKEDIN LINK AVAILABLE
Street Address C: PHONE NUMBER AVAILABLE E:
EMAIL AVAILABLE
EDUCATION:
Northeastern University- College of Professional Studies Boston,
MA
Master of Science, Regulatory Affairs in Drugs, Devices and Biologics Exp. Dec
2017 (Concentration: General)
Relevant courses: New drug development, Medical device, Biologics, Human experimentation, Canadian and
Latin American PV
Swami Devi Dyal Hospital and Dental College
Panchkula, India
Bachelors of Dental Surgery Jan 2014
EXPERIENCE:
PAREXEL
Chandigarh, India
Pharmacovigilance scientist Nov 14
Dec 15
Assisted a team of 20 in triaging of ICSRs to determine their qualification for expedited reporting
Coordinated with the team and checked timeline for submission to the regulatory authorities
Interacted with appropriate client personnel to resolve issues related to the processing of ICSRs
Conducted duplicate searches prior to registration, identified potential duplicates and managed
appropriately
Validated data- cross checking against source documentation
Entered initial and follow-up information for individual AE case reports onto the Drug Safety
database in accordance with the current Data Entry and Process Instructions and associated SOPs.
Utilized safety databases to log, track, prioritize, and to respond to product complaints and serious
adverse events (SAEs).
Determined follow-up requirements and recommend follow-up type (phone call, letter, etc.); formulate
and generate queries.
Built and maintained a good working relationship with associated Project management, medical
writing and regulatory affairs group
Documented classification of Adverse Drug Event (ADE) reports according to the following criteria:
source, serious and non-serious, data entry priority, initial vs. follow-up report.
DENTAFIX MULTISPECIALITY CLINIC Chandigarh
India
Assistant dentist Feb 14
Nov 14
Performed dental procedures like ceramic filings, root canal treatment, oral prophylaxis, crown
shaping, tooth extraction.
Assisted the head dentist with extensive dental surgeries
Provided patients with after surgery dos and donts and instructed them rules to maintain oral hygiene.
Maintained patient record at the dental clinic and sending reminders to the patients for future
appointments.
UNIVERSITY OF TEXAS HEALTH SCIENCE CENTRE SCHOOL OF PUBLIC HEALTH Houston,
Texas
Graduate Assistant Sep
2014
Worked for the department of student affairs for the month of September 2014
Assisted the school admissions department to sort out admission applications for prospective student
Maintained high confidentiality with student scores and mark sheets information
Performed all clerical tasks including answering phone calls on behalf of student affairs
Maintained records for student affairs with respect to student forms
NORTHEASTERN UNIVERSITY Boston,
MA
Facility assistant Sep 16
Present
Help the college athletics department maintain the facility equipments.
Assist them with maintaining the decorum of the facility by not allowing outsiders in the facility.
SKILLS
Performed case triaging of incoming reports and case booking activity
Case Processing and Adverse Event Reporting, Narrative Writing and assessment
MedDRA drug dictionary, Causality assessment, De-challenge and Re-challenge
determination
Data entry of case information in Drug Safety Tools and Adverse Event Coding
Adhering audit compliance and participating in client meetings
Firm knowledge of drug safety database Argus and trained in AWARE
Proficient in medical terminology and scientific terms.
Executed individual class projects learning the basics of 510K, BLA, NDA applications.
Skilled in MS Word, Excel, Outlook and Access
ACADEMIC PROJECTS
Prepared mock end of phase II letter to request a formal meeting with the FDA.
Performed really well in the due diligence assignment
Assessed warning letters and prepared a CAPA as a part of class assignment.
Planned the regulatory pathway for the development of a biosimilar product.
VOLUNTEER EXPERIENCE
Red Cross Society Haryana, India
(2012-2014)
Conducted blood donation camps.
Provided health education, delivered lectures on importance of oral health care
Taught preventive health care techniques to underprivileged people.
Rotaract club Chandigarh, India
(2012-2015)
Organized various healthcare camps and public health initiatives in its various initiatives
towards society providing various dental care reforms.
Organised fund raising events to support orphanage and old age homes.
Indian dental association Chandigarh,
India (2014)
Volunteered in many diagnostic dental camps to educate the patients regarding their oral
health.
Conducting various oral healthcare camps and health education programs and public health
initiatives.
OTHER RELEVANT ACHIEVEMENTS
Registered dentist at Haryana dental association, India
Conducted clinical research study on 200 dental students titled Evaluation of Stress among
Dental Students which published in Journal of Pharmaceutical and Biomedical Sciences , in
November 2013 issue.
Published an article Dental Tourism in India in "Journal of Pacific Academy of Higher
Education & Research, 2012; Vol.4: Issue 1. July-set
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