Senior Safety Specialist - remote
Company: Precision For Medicine
Location: Saint Louis
Posted on: May 15, 2022
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Job Description:
Senior Safety Specialist is an integral part of the safety team
at Precision and performs all aspects of the collection,
processing, and reporting of individual cases safety reports (ICSR)
for clinical trials and/or post-marketing safety programs.
Position Summary
Responsibilities will include, but may not be limited to; safety
management plan development, serious adverse event (SAE, SUSARS)
case management from intake to regulatory reporting, and providing
safety expertise in a timely manner upon request from team members,
clients, and study site personnel.
Essential functions of the job include but are not limited to:
Interfacing with sponsors, vendors, and other internal team members
in the area of safety to assist in the design and implementation of
safety collection tools, processes, and reporting systems
Participate in the assessment and set-up of a safety database to
capture SAE data
Perform intake, triage, data entry, medical coding, expectedness
assessment, and composition of narratives and analyses of similar
events for individual case safety reports (ICSRs), while following
applicable regulations and company policies and procedures
QC of documents and safety reports
Preparation and/or review of project-specific safety reporting
plans and medical coding plans
Preparation and/or review of safety training materials
Provide safety training and oversight for consultants, contractors
and/or staff
Review and/or draft standard operating procedures and work
instructions
Assist clients and/or other departmental staff with safety-related
reviews and other services
Other duties as assigned
Minimum Required
Qualifications:
BA/BS degree
Minimum 3 years clinical safety experience
Other Required
Health care professional
Hands on experience with global safety database(s), SAE case
processing, and safety reports generation
Working knowledge of MedDRA and WHO Drug
Working knowledge of FDA safety regulations, ICH guidelines, and
global safety regulations
Preferred
Nursing or pharmacy degree
Industry experience in CRO or pharmaceutical company
Any data provided as a part of this application will be stored in
accordance with our Privacy Policy .
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process, or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .
Keywords: Precision For Medicine, St. Louis , Senior Safety Specialist - remote, Other , Saint Louis, Missouri
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