(strong(Pre IPO Class III Medical Device Company(/strong((br /((br /(This Jobot Job is hosted by: Victoria Casal(br /(Are you a fit?
Easy Apply now by clicking the “Apply” button and sending us your resume.(br /(Salary: $130,000
– $165,000 per year(br /((br /((strong(A bit about us:(/strong((br /((br /(Pre IPO Class III Medical Device company.
We are passionate cardio vascular disease and bringing our ideas and technology to the healthcare world.(br /((br /((strong(Why join us?(/strong((br /((br /(We offer the following; (br /((ul((li( Competitive base (/li((li( Yearly bonus (/li((li( Stock Options (/li((li( PTO and holiday week break!
(/li((li( 401K (/li((li( FULLY REMOTE(/li((/ul((br /((br /((strong(Job Details(/strong((br /((ul((li( Main point of contact for Clinical Safety activities.(/li((li( Initiate and manage study specific safety plans, as applicable.
(/li((li( Provide medical safety oversight for sponsor’s clinical studies.
(/li((li( Interact with site coordinators and monitoring team for the purposes of safety data collection and data reconciliation.
(/li((li( Communicate with site investigators, as needed, to discuss complex adverse events.
(/li((li( Report complaints to QA according to regulatory requirements, trial safety processes and standard operating procedures.
(/li((li( Conduct SAE reporting according to regulatory requirements and region-specific guidelines.
(/li((li( Work along side regulatory authorities in responses to process and/or safety-related queries(/li((li( Review quality assurance of CEC packets and adjudication results.
(/li((li( Provide safety and medical expertise to Quality Compliance/Complaint Handling on medical aspects of reported complaints.
(/li((li( Prepare or review complex event narratives for internal use (e.g., medical affairs, quality, RA) or external review (Clinical Endpoints Committee), as well as for regulatory submissions, as needed.
(/li((li( Provide input on clinical trial protocols, safety endpoints and definitions, and help develop safety sections of study protocols.
(/li((li( Review and provide input to regulatory (FDA, OUS competent authorities) and clinical reports and submissions.
(/li((li( Represent safety in internal and external audits.(/li((/ul((br /((br /(Interested in hearing more?
Easy Apply now by clicking the “Apply” button.