Safety Scientist
Company: Kelly Services
Location: Levittown
Posted on: April 9, 2021
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Job Description:
Kelly Services-- has been providing outstanding employment
opportunities to the most talented individuals in the marketplace.
We are proud to offer a long-term temporary opportunity to work as
a Safety Scientist at a prestigious Fortune 500-- company working
in Lawrenceville, NJ--Important information:--This position is
recruited for by a remote Kelly office, not your local Kelly
branch. To be considered for this position, you must use the
"Submit Resume" button to submit your resumes. If you have
questions about the position, you may contact the recruiter for
this position () however your resume must be received via the
"Submit Resume" button included within.--Job Title: Safety
Scientist--Pay: $50.91 per hour --List Major Skills Required:---
Experience writing narratives for study drug safety reports.---
Experience using a drug safety database to capture adverse
events.--- Experience applying medical knowledge in a business
context.--- Experience working in a post-marketing safety or
clinical trial setting (i.e., CRO, pharmaceutical company and
academic setting).--- Experience working in teams, including
supporting other team members when necessary.--- Strong teamwork
(with ability to lead a team) and prioritization skills to ensure
that processes, procedures and best practices are consistent across
GPV&E and that Regulatory requirements are met in a timely
manner with high quality.--- Ability to make constructive
recommendations to improve processes.--- Demonstrates the ability
to multi-task, and flexibility to meet changing business
priorities.--- Maintains an in-depth knowledge of the ARGUS Safety
Database and Clinical Databases such as RAVE/Trial Access Online
etc, and is able to query the systems to support the SUSAR/ESR
scientist role.--- Ability to collaborate within multi-disciplinary
team on drug safety-related issues including informing safety
physicians and scientists within the therapeutic area on
case-related issues.--- Ability to apply sound analytical thinking
and database query skills to gather, review, summarize and evaluate
critical information in a timely manner.--- Strong knowledge of
SUSAR process, SOPs, conventions and health authority regulations
worldwide, to ensure all safety information is accurate, integrated
and current, and is submitted within regulatory timelines.---
Utilizes medical, scientific and clinical knowledge in reviewing
safety-related documents (e.g. protocols, investigator brochures,
product labels, relevant source documents) and incorporating key
concepts to clearly present the reported events, and in turn,
maintain patient safety.--- Possess medical writing skills to
produce accurate, concise, medically sound expedited reports.List
Responsibilities Required:--- Ability to support GPV&E Vision
and Mission through an understanding of the impact and implications
of daily work on all customers of the Expedited Safety Report
Group.--- Medical and pharmaceutical knowledge (i.e., scientific
understanding of the human body and its functions).--- Knowledge
and understanding of Health Authority Regulations worldwide, how to
access them and when to refer to them.--- High level of knowledge
and experience using ARGUS, MedDRA, and RAVE/Trial Access
Online/J-Review.--- In depth Knowledge of computer applications and
project planning skills.--- Mastery of GPV&E and R&D SOPs,
drug safety coding conventions, and work.--- Provide technical
support to GPV&E medical review safety physicians (MRSP)
including review and interpretation of source documents.---
Participate in the evaluation of serious adverse event reports from
spontaneous reports, clinical trials, non-clinical reports and
scientific literature.--- Identify additional information required
from investigators and collaborate with MRSP to prepare queries to
obtain additional information.--- Utilize ARGUS database and
J-Review to prepare contextual summaries for expedited safety
reports.--- Review and comment on documents and line listings from
GPV&E, other departments, and other drug development/marketing
partners and contractors.--- Ad Hoc member of Medical Surveillance
Team.--- Perform Analysis of Similar Events for potential DILI and
events of special interest.--- Serve as a resource for GPV&E
information and help develop and participate in and/or lead teams
involved with developing or revising GPV&E
SOPs.--Education:B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S.
Pharm./R.Ph./Pharm.D. or equivalent.Years Of Experience Preferred:4
years experience in a clinical development setting or 2-3 years
Safety experience within the pharmaceutical industry.--We invite
you to bookmark our Web site and encourage you to review it
regularly for new opportunities worldwide: .Kelly Services-- is a
U.S.-based Fortune 500 company. With our global network of branch
locations, we are uniquely positioned to provide our customers with
international staffing support and our employees with diverse
assignments around the world.Kelly Services is an Equal Opportunity
Employer------Why Kelly--?Kelly Science & Clinical is your
connection to premier scientific and clinical companies looking to
hire talented people just like you. Every day, we match science
professionals with dream jobs that fit their skills and
interests-it's the way we think job searching should be. Nearly 100
percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Law.]]
Keywords: Kelly Services, Levittown , Safety Scientist, Other , Levittown, Pennsylvania
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