About this role
Role Overview
- Provide medical safety expertise, directly and indirectly, to Sponsors undertaking clinical trials of drugs, devices, and combination products
- Responsible for medical review of serious adverse events and adverse events of special interest from Clinical Trials
- Develops new and enhances existing client relationships whenever possible
- Provides medical/safety expertise to colleagues within PSS
- Responsible for preparation and medical review of Aggregate Reports required by global regulatory agencies
- Provides safety support/expertise to project physicians
- Presents Safety capabilities to clients
- Responsible for medical review of serious adverse events and non-serious adverse events from spontaneous reports
Requirements
- MD or DO with at least one year of postgraduate training or equivalent
- Substantial knowledge of drug / device safety and the underpinning global regulations
- At least 4 years of experience working for a pharmaceutical company, health authority or a contract research organization in Safety or related fields such as QA, Regulatory Affairs, medical writing, or clinical medical monitoring
- MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years experience
Benefits
- Health insurance
- Professional development opportunities
- Office Environment or remote
- Regional travel for client meetings