For further information please contact our Talent Specialist: Rashi | Title: Medical Safety Reviewer Location: Columbus, OH Duration: 12 Months Schedule: Onsite 4 days and 1 work-from-home day Description: This position is Non Exempt. Hours over 40 will be paid at Time and a Half.
Responsibilities include 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. 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. 0-3 Years Experience Level. Will be supporting a new team mostly based in the UK. Working hours will still be Eastern business hours. Looking for candidates with Bachelor's preferred in Nursing or Dietitian The team is looking for candidates that have a clinical background more than Med device or Pharma As an individual contributor, with guidance from the manager/team, functions to support the medical safety team by collecting, assessing, processing adverse events for clinical or post-marketed products in compliance with applicable regulations, guidelines, researching, assessing and summarizing nutrition and medical information as well as safety issues concerning foods or products and, by supporting clinical study teams with safety-related aspects and issues.
Responsibilities:
Collecting, assessing and processing adverse event information in a compliant and timely manner in order to meet applicable regulatory requirements.
Coding cases using appropriate dictionaries, searching and inputting data in electronic databases.
Generating, tracking and resolving adverse event follow-up/distribution correspondence; managing adverse event reports from initial cases and follow-up.
Assisting in the completion of MSS related analyses, reports, and/or projects as assigned, e.g., ingredient and finished product assessments and/or medical safety assessments.
Presenting MSS-related analyses, reports, and/or assessments orally and/or in writing within the department.
Researching, organizing and assimilating clinical, safety, and/or toxicology information to support medical safety assessments, clinical study related safety reports, safety fact sheets and chemical approvals.
Assisting in the generation of medical justification content reviews/templates for MSS and looking for a candidate with more of a nutrition background; a dietitian or someone with some nutrition science undergraduate work for example.
Skills:
Some industry experience is desirable.
Clinical knowledge to apply to adverse event data collection and/or medical/product assessments.
Computer proficient (Windows, Word, Excel) and proficient in specific adverse event databases (as applicable).
Able to present case data, medical and scientific data orally and in writing.
Clinical Monitor or Research Coordinator
Education: Associate or Bachelor's degree preferred in Healthcare or Science. Will consider someone directly out of college.
Interview: In-person
About us: DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
