Medical Reviewer/Safety Reviewer II
Company: PSG Global Solutions Careers
Location: Lake Bluff
Posted on: May 26, 2023
Job Description:
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The Opportunity
Description
We're looking for a Medical Reviewer/Safety Reviewer II, working in
Healthcare Systems and Services industry in Lake Bluff, Illinois,
United States.
Job description:
- Participates in applicable safety surveillance activities for
assigned products; and in planning and completion of AdHoc Safety
Reports as needed.
- Timely assessment of adverse event coding for consistency and
accuracy of coding and accurate and effective medical review of
safety related CRFs and labs, including communication with Study
Designated Physicians by interfacing with study manager, Clinical
Research Organizations, Clinical Research Associates, Data
Management, Pharmacovigilance and others to assure query
resolution.
- Supervise tracking of safety related queries to Investigators
and assists in handling safety questions from IRB/IEC.
- Assist with Study Safety Review Plan development and
implementation in collaboration with Study Designated Physicians
and provides Safety overview to Clinical team members, Clinical
Research Organizations, Investigators and investigator sites as
needed and review study protocols, IND reports, annual reports,
Investigator Brochures, Safety sections of the Clinical Reports,
Monitoring Plans, IDMC data and other ad hoc reports which include
safety data.
- Create narratives of serious adverse events and other
identified events of interest in accordance with accepted standards
and with high degree of competency.
- Apply knowledge of ICH, FDA, EMA regulations and guidelines
affecting drug and disease state, understanding issues to assigned
responsibilities with an in depth understanding of product
labeling/literature, including safety profile. Understand,
implements and improves department SOPs. Clinical knowledge to
apply to adverse event data collection and assessment.
- May serve as a representative for Safety Management on cross
functional projects, but does not assume decision making.
Our Client
Our client is an award-winning clinical development company.
Improving lives globally with 20+ years experience in clinical
research and strategic resourcing. Elevating results with proven
strategies, comprehensive solutions, and customized delivery
models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and
medical device organizations.
Strong relationships provide you connections and access to great
opportunities. Industry expertise sets you up for success with
helpful insights, career coaching, and professional training. Grow
and learn while you put your skills to work.
Experience Required for Your Success
Requirements:
- Bachelors degree with related health science background is
required
- RN or clinical pharmacy experience strongly preferred
- Minimum 3 years clinical experience with a minimum of 1 year
drug safety/pharma experience (or) 2 years clinical experience with
a minimum of 3 years drug safety/pharma experience
- Proficiency in Computers (Windows, Word, Excel) and in specific
databases (e.g., oracle/clinical, PIMS, laboratory databases)
- Ability to critically evaluate medical data
- Ability in accurately and medically presenting; of case data,
both orally and in writing
- Ability to identify, prioritize and assign tasks to others in
Clinical Safety Manager's absence
What Do You Think?
Does your experience reflect what it takes to be successful in this
role? Do the work and challenges get you excited about what's
possible?
Keywords: PSG Global Solutions Careers, Waukegan , Medical Reviewer/Safety Reviewer II, Healthcare , Lake Bluff, Illinois
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