Clinical Safety Specialist
Registrat Mapi - Lexington, KY

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REGISTRAT-MAPI (www.registratmapi.com) is the industry's largest Clinical Research Organization (CRO) dedicated solely to "real-world" clinical research. We provide strategic and operational expertise as well as services in the design and conduct of late phase studies globally. We are committed to developing true partnerships with ourbiopharmaceutical and medical device company clients. Our people reflect the vision and mission of our organization and are experienced experts in Late Phase research. Importantly, the systems and processes supporting our team also embody that focus with technologies, business partners, and our methodologies all reflecting the unique challenges of research in the real-world.REGISTRAT-MAPI is seeking a Drug Safety Specialist to add to our team headquartered in Lexington, KY or Remote USA ! With your Bachelor's Degree, and a minimum of three (3) years' work experience in either a clinical research setting, biopharmaceutical setting, or academic setting, we want to talk to you today! Position Description: Responsible for management, processing and reporting of adverse events in compliance withREGISTRAT-MAPI and project specific SOPs and applicable regulatory authorities. Provide support for the clinical services business area as part of the clinical services team.Responsibilities: Perform data entry/verification of event in safety database.Determine classification of AE.Follow-up with sites to collect supporting documents.QC data entry with supporting documentation.Code adverse events.Prepare and QC case narratives.Prepare safety reports and summaries for manufacturers and regulatory authorities.Assist with reconciliation of clinical and safety databases.Prepare and report adverse events in compliance with applicable regulations of international regulatory authorities.Prepare and report adverse events in compliance with REGISTRAT-MAPI and project specific safety SOPs.Review, revise, and develop new (as applicable) SOPs for safety processing and reporting.Provide suggestions for enhancements to REGISTRAT-MAPI safety system.Serve as a resource to internal departments, sponsors, and for business development purposes.Assist with clinical development functions e.g., protocol and CRF development.Provide support in the area of new business RFP evaluation and presentation of company capabilities to potential clients.Assist in the development of the clinical services area by serving in initiatives designed to improve the quality and composition of our services.Travel may be required for client and potential client meetings.Additional duties and responsibilities as required.Qualifications: Candidate must have an R.N., B.S.N., Pharm.D., M.S.N., or other health-related degreeMinimum 3-5 years' relevant industry/clinical experience, preferably in drug safety, including CRA experience with anunderstanding of the SAE processing environment in which drug safety operates.Knowledge and experience with regulatory adverse event reporting requirementsOutstanding computer proficiency and writing skills. Minimum 3-5 years' previous clinical safety experience is required. As an Equal Opportunity Employer, we are committed to a diverse work force.

Keywords: Pharmacovigilence, Drug Safety, BSN, MSN, PharmaD, Clinical, Nurse

Registrat Mapi - 17 months ago - save job - block
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