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13 days old

Medical Review _ Safety Reviewer _ North Chicago, IL

Kelly Services
North Chicago, IL 60064
**Medical Reviewer / North Chicago, IL**



Kelly Services is currently seeking a Medical Reviewer for one of our top clients in North Chicago, IL



As a Medical Reviewer placed with Kelly Services you will be responsible for medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level.





**JOB RESPONSIBILITIES:**




+ Collects, analyzes and triages adverse events and reviews safety-related data from clinical trials. Adherence to regulatory guidance, Protocols, and departmental processes under minimum supervision as this position could impact safety signal identification and patient safety.

+ Triages incoming SAE information in order to fulfill timely reporting according to the authority/regulatory requirements.

+ Participate in safety surveillance activities for assigned products; and also in area projects/goals. Identify and escalate problems to manager.

+ Collecting, analyzing, and triaging Adverse Events including reporting Serious Adverse Events to IND safety including follow-up.

+ Timely assessment of adverse event coding for consistency and accuracy of coding.

+ Timely, accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians.

+ Interface with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, and Pharmacovigilance to assure query resolution.

+ Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.

+ Work closely with study-specific contacts such as; Clinical Safety Manager, clinical research organization, clinical research associates, data management, and pharmacovigilance.

+ Responsible for clinical safety capture and report, as workload responsibilities are study-related and have a major impact on regulatory compliance and product safety profile.

+ Follow scientific arguments and identify safety data needs and adhere to resolution of data completeness regarding all aspects of clinical safety that impact product approval, safety signal identification, and patient safety.

+ May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.



**JOB REQUIREMENTS:**




+ Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.

+ 2 years clinical experience is required 3 5 years experience preferred

+ Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.

+ Sound understanding of product labeling/literature, including safety profile.

+ Able to apply clinical knowledge to adverse event data collection and assessment.

+ Competent in ability to present adverse event data, orally and in writing.

+ Adheres to policies and regulations.

+ Must be Computer proficient (Windows, Word, Excel).





Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. You can email stalvnl@kellyservices.com for questions.





Why Kelly?






+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*





Apply Today!





*Available for purchase and administered by a designated third-party vendor






**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-09-11 Expires: 2020-10-12

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Medical Review _ Safety Reviewer _ North Chicago, IL

Kelly Services
North Chicago, IL 60064

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