Upvote
Downvote
Associate Director, Global Clinical Safety - Medical Devices (on - Site)
Share Job
- Suggest Revision
- Reporting to the Global Safety Director, this position will provide leadership, management, and direction for Clinical Safety for Abbott’s clinical trials.
- Support projects or other initiatives from cross-functional groups and departments (i.e., Project Management teams, Scientific group, Quality/Compliance, Data Management, Biostatistics and Regulatory Affairs), and ensure adequate safety support and timely update of safety information to internal and external stakeholders.
- Provide support and review study-specific documents for clinical trials including CIP, safety-related case report forms, and design of tables and listings for safety data from clinical studies to present to independent committees.
- Provide staff training and mentoring; monitor performance of direct reports and provide constructive feedback and coaching.
- Manage and provide oversight of activities performed by the Safety Specialists and Safety Monitors, including but not limited to quality review and assessment of SAEs, SAE and Device Deficiency reporting, event trending, narrative writing, appropriateness of queries to clinical sites, and accuracy of MedDRA coding.
Active Job
Updated TodaySimilar Job
Relevance
Active