Safety Quality Assurance
Resume:
Jyotsna Gupta
Jersey City NJ ****0
Ph.: 347-***-**** email:
**********@*****.***
Summary:
> Received and tracked information regarding potential adverse events
submitted by all reporters including consumers, healthcare
professionals, co-manufacturers, call centers, medical information
centers, quality assurance and other company representatives
accurately with in defined reporting timelines.
> Hands-on expertise in start to end of Case Processing (unsolicited,
solicited and literature reports) in Pharmacovigilance data bases such
as ARGUS, ARISg and Oracle AERS.
> Effectively maintain the safety data base and corresponding entry
guidelines with assurance of quality of data.
> Efficient in identifying and tracking the serious adverse events and
non-serious adverse events.
> Proficient in consistent coding of diseases, adverse events, and
medication according to the Project-specific coding conventions.
Experienced with WHODD, WHOART and MedDRA coding.
> Knowledge of study activities, coding, review and clarification
activities.
> Processed serious adverse event (SAE) and non-serious adverse event
reports, both individual and aggregated reports from post marketing
and clinical studies.
> Processed serious adverse event information per sponsor's standard
operating procedures.
> Drafted individual case summary reports and wrote concise case
specific narratives as per company/product conventions.
> Interaction on a regular basis with contract clinical research
organizations (data management, case processing, call center) to
resolve safety-related issues.
> Attended internal meetings and summarize weekly documentation for
studies.
> Used to identify adverse events, seriousness, and
listedness/labeledness for case completion.
> Prepared clinical narrative summaries independently for AE reports
from clinical studies and spontaneous post-marketing reports and
formulated follow-up information as per requests.
> Accurately entered data from source documents/ call center reports/
medical reports and proofread for completeness, accuracy and
consistency of information.
> Sound Knowledge of FDA, EMEA and ICH regulations.
> Performed review of NDA and MAA documents.
> Assisted with Clinical Trial database reconciliation with safety
database.
> Assisted in consolidating IND annual safety reports and periodic
safety update reports.
> Collected outcomes (AE's, Interim variables and endpoints) to maintain
the study objectives.
Professional Experience:
Drug Safety Associate
Nov 2011- Present
Purdue Pharma
> Reviewed spontaneous reports as well as cases from clinical trials for
marketed and investigational compounds to determine regulatory reporting
responsibilities, identified required follow-up information, and wrote
assessments for international and local cases processed within regional
center.
> Determined potential impact of safety data on product labeling and
development status.
> Worked with medical safety monitor and European regional center in
analysis of safety signals, assessment of potential expectedness,
seriousness, causality, drug-related toxicities.
> Recommended updates to the company core data sheet and assisted in
preparation of Investigator Notification letters.
> Reviewed local product labeling for marketed drug, manuscripts,
publications and press releases.
> Co-authored, reviewed and updated medical safety information documents,
including Investigational Brochure (IB), safety section of protocols, and
risk assessment plans.
> Responded to regulatory agency inquiries regarding product safety and
assisted with FDA inspections within drug safety department.
> Communicated potential safety issues, activities and accomplishments to
upper management.
> Assisted in consolidating IND annual safety reports and periodic safety
update reports.
> Processed serious adverse event information per sponsor's standard
operating procedures.
> Submitted ICSR's to the regulatory authorities in a timely manner.
> Performed medical coding using MedDRA and WHO drug/CDD.
Drug Safety Associate
May 2009 - Oct 2011
Forest Laboratories, NJ
> Determined the reportability of cases to local and international
regulatory authorities and submission of cases in a timely manner per
respective reporting requirements.
> Analyzed cumulative investigational and marketed product adverse event
reports for inclusion in Periodic Safety Update Reports.
> Authored individual case assessment summaries and narratives,
investigational and marketed product Periodic Safety Update Reports and
Annual Reports.
> Interpreted aggregate safety data; determine potential impact of safety
data on product labeling or development status of investigational
compounds.
> Accept E2B cases received through the Argus Electronic Submissions
Module (ESM).
> Monitor electronic mailboxes and Argus ESM to ensure timely acceptance
of Adverse Event (AE) Reports and perform data entry into databases,
as needed.
> Developed, authored and managed safety documents, such as
Pharmacovigilance Plans and Risk Management plans submitted to the FDA
and to the EMA.
> Developed complete responses to FDA inquiries regarding
investigational and marketed product safety which presented accurate
benefit-risk information and supported company initiatives.
Research Biologist Sept 2008-April
2009
MERCK & Co. Inc, RAHWAY, NJ (Genetically Engineered Models (GEM)
Department)
> Principally responsible for conducting in vivo studies to support the
RNAi research programs
> Conducted phenotypic and gene knockdown studies on translational in
vivo model including but not limited to preparing the study protocol,
design and implementation of the in vivo study and measuring the study
endpoints using gene knockdown analysis.
> Prepared end of study reports on Electronic Lab Notebooks
> Supported various siRNA studies by evaluating the knock-down of
various genes using RT-PCR.
> Experienced user of various automated machineries -automated DNA and
RNA sample prep, liquid handler, RNA analyzer, RNA purifier, high
throughput sample disrupter
> Managed the entire mouse colony for GEM: breeding of 20+ transgenic
mouse lines handling over 600 animals.
Education:
Columbia University in the city of New York, USA
Masters of Arts, Biotechnology Jul
2008
Cumulative GPA: 3.5
SJPMIT, Kurukshetra University, India
Bachelors of Technology, Biotechnology Jul
2005
GPA: 3.9
Skills:
> Working experience with the Microsoft suite of programs (Word, Excel,
PowerPoint, and Outlook).
> Demonstrated Good Documentation Practices while doing reconciliation
process.
> Demonstrated SOP/WP writing skills along with regulatory documents.
Contact this candidate