To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02410

About our client Our client is a global CRO with over 30 years of successful history in the execution of complex clinical trials. The company has an experienced management team and is known for their innovative study designs, state-of-the-art facilities and strong regulatory intelligence. They are able to offer an empowering corporate culture that is ideal for professionals that possess a high degree of drive and initiative. Position Location Medical Affairs Associate Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare, analyze, and follow-up of adverse event (AE) and serious adverse event (SAE) reports from Phase I to Phase IV in compliance with company SOPs and applicable guidelines 2) Ensure data accuracy, clinically valid case assessment and regulatory reporting status assessment 3) Serve as a primary point of contact for specific projects in addition to provide safety support and expertise on cross-functional project teams 4) Write, review and revise AE & SAE reporting procedures 5) Receive, document and process AE & SAE reports 6) Document procedures and responsibilities for all clinical safety team members per project requiring safety surveillance 7) Review data coding 8) Provide medical expertise for logic checks; interpret lab test reviews and normals 9) Maintain files 10) Work interdepartmentally to develop SAE tracking systems and information flow processes 11) Manage safety surveillance SOPs 12) Prepare and review budget proposals Requirements 1) M.D (foreign or domestic) 2) Pharmacovigilance experience in pre-market phases (I-III) 3) Minimum 5 years of experience 4) Minimum experience of 1 year in Clinical Safety or Drug Safety 5) Familiar with FDA drug safety reporting requirements 6) Knowledge and experience of safety concepts, focused on standards set out in ICH and FDA, and the European Clinical Trials Directive guidelines for safety reporting requirements 7) Attention to detail 8) Excellent communication and interpersonal skills