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Associate Medical Director – Safety Physician
FortreaProvide medical safety expertise and support for Sponsors undertaking clinical trials of drugs and devices. Develop and enhance client relationships while ensuring compliance with safety regulations.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Health insurance
- Professional development opportunities
- Office Environment or remote
- Regional travel for client meetings
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical reviewadverse event analysisaggregate report preparationclinical trial expertisedrug safety knowledgedevice safety knowledgeregulatory compliancemedical writingclinical medical monitoring
Soft Skills
relationship developmentcommunicationcollaborationpresentation skills
Certifications
MDDOboard certification