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Clinical Safety Specialist

Company: Actalent
Location: Bellevue
Posted on: September 21, 2022

Job Description:

Seeking a Clinical Safety Specialist100% RemoteDescription:-Oversight of the safety program of all clinical trials. This includes tracking and assessment of adverse events for reportability and for those that require adjudication.-Author study specific safety documents and plans (eg: CEC Charter, Adverse event adjudication plan, etc.).-Manage and provide guidance to the Clinical Events Committee (CEC); inclusive, but not limited to, coordinating CEC meetings, preparation of safety dossier packages, and oversight of the adverse event adjudication process.-Collaborate with sites/CRA to ensure comprehensive information is available for full review of adverse events.-Conduct aggregate safety assessment and trending against current thresholds for events of special interest and assist in escalation, including communication to Medical Safety Officer and study/ senior management.-Provide safety-related input to study documents/processes as requested (eg: CIP, CRF design, annual reports, study reports etc.).-Manage adverse event processing including report review, safety query management and expedited reporting.-Ensure consistency and compliance in application definitions for event adjudication outcomes-Coordinate, participate in the preparation for, and attend (as applicable), CEC and DMC meetings.-Ensure consistency and compliance in application of protocol definitions for adjudication outcomes.-Participate in preparation of weekly regulatory submissions of events meeting expedited reporting criteria according to specific country regulations.-Perform coding of adverse events and medical history using the MedDRA dictionary, and adherence to study coding convention documents.-Manage translations of appropriate safety documentation as needed, by working with study vendors-Contribute to the development and implementation of the safety program, process improvements and practices.-May be asked to perform other Clinical responsibilities, as needed.Skills:Clinical trial, CEC, CEC Committee, adverse event reporting, Safety, Clinical development, Protocol designAdditional Skills & Qualifications:Qualifications:LVN, RN or BS in Health Sciences, or higher equivalent education in relevant disciplines6+ years of clinical safety and study experienceExcellent computer, organizational and multi-tasking skillsAbility to effectively communicate across all levels of the organizationFamiliar with IDE, PMA, 510(k) or equivalent and GCP proceduresKnowledge of adverse event reporting regulations such as 21CFR812, MEDDEV 2.7/3 and ISO14155:2011Experience Level:Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Bellevue , Clinical Safety Specialist, Other , Bellevue, Washington

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