Associate Medical Director Safety Physician

**Job Overview:** Provide medical safety expertise, directly and indirectly, to Sponsors undertaking clinical trials of drugs, devices, and combination products, and in the post marketing period. **Summary of Responsibilities:** * Responsible for medical review of serious adverse events and adverse events of special interest from Clinical Trials in support of safety activities for clients. * Develops new and enhances existing client relationships whenever possible. * Provides medical/safety expertise to colleagues within PSS, including communicating information regarding safety regulations and any changes that have occurred. * When applicable, responsible for preparation and medical review of Aggregate Reports (such as Periodic Adverse Drug Experience Reports – PADERs) required by global regulatory agencies for review of safety information for assigned products. * Provides safety support/expertise to project physicians, as appropriate. * Presents Safety capabilities to clients as part of a proposal team, when appropriate. * When applicable, responsible for medical review of serious adverse events and non-serious adverse events from spontaneous reports and reports derived from regulatory authorities and the medical literature during post marketing surveillance in support of safety activities. * When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products. * All other duties as needed or assigned. **Qualifications (Minimum Required):** * MD or DO with at least one year of postgraduate training or equivalent, having substantial knowledge of drug / device safety and the underpinning global regulations. * Fortrea may consider relevant and equivalent experience in lieu of educational requirements. **Experience (Minimum Required):** * 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. **Preferred Qualifications Include:** * MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years’ experience. **Physical Demands/Work Environment:** * Office Environment or remote. * Travel is primarily Regional for client meetings, with 5% of the time, and with 75% of that time requiring an overnight stay. Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).