Drug Safety Navigator (DSN)
Molly James has extensive experience in drug safety and pharmacovigilance, holding various leadership positions in reputable companies such as Drug Safety Navigator, LLC and Five Oaks Pharm, LLC. With a background in nursing from the University of Michigan, Molly has successfully managed safety-related functions, oversaw adverse event processing, and provided pharmacovigilance support and guidance throughout their career.
This person is not in any teams
Drug Safety Navigator (DSN)
Drug Safety Navigator LLC (DSN) helps companies navigate the complexities of drug safety compliance. We support small to medium-sized pharmaceutical companies, biotech firms and CRO's at various stages of drug or medical product development. DSN works both on a project basis as well as serving as a full virtual safety department for our clients. Our services include Adverse Event Reporting, Regulatory Inspection preparation, Safety Signal Reporting. We also offer support for Individual Case Safety Reporting, Medical Writing & Monitoring, and Adverse Event Coding (MedDRA, WHO Drug, etc.) Our mission is to provide continuous innovation, outstanding quality, and cost-effective solutions that will maintain regulatory compliance and promote patient safety.