Home-Based Clinical Safety Coordinator - Pharmacovigilance / Drug Safety
TR
International Careers
Req #: 11327
Type: Full-Time
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Overview: Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities: * Collect, process, and track serious adverse event (SAE) reports * Generate safety narratives and queries * Safety Database data entry * Perform quality control of safety cases * Generate Investigator Safety Letters * SAE reconciliation between safety database and clinical database * TMF uploads and quality control review * Preparation of clinical safety documents as required (i.e., safety management plan, periodic safety reports and presentations) * Attending internal and external meetings, as required (including sponsor TCs and audits/inspections) * Leading clinical trial projects (ensure client deliverables are met, provide oversight and compliance reports) Additional Responsibilities * Develop presentation material and present during face-to-face Sponsor meetings (i.e., Kick-off Meetings, Investigator Meetings) * Coordinate final medical review of study report narratives and submission to Medical Writers * Develop drafts of adjudication material (i.e., charter, reporting materials) * Provide periodic safety summaries to project Data Manager, Clinical Trial Manager, and Medical Monitor * Train new Clinical Safety Coordinators on safety reporting responsibilities * Coordinate safety responsibilities for aggregate reporting purposes (e.g., ensure timely data entry, tracking of pending cases, collaborate with Medical Monitor and Regulatory Affairs) Qualifications: * Minimum Bachelor's life science degree * 2+ years of Clinical Trial Pharmacovigilance experience * Working knowledge of Safety Databases (Argus is desirable) * Demonstrate advanced knowledge of medical terminology, global safety reporting requirements and Good Clinical Practice (GCP) Guidelines * Exposure to working on global trials as part of a multidisciplinary team * Fluent in English and Turkish
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