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Associate Medical Director – Safety Physician
FortreaProvide medical safety expertise during clinical trials and post-marketing evaluations for drugs and devices. Responsible for medical review and support for client safety activities in clinical trials.
About the role
Key responsibilities & impact- Provide medical safety expertise, directly and indirectly, to Sponsors undertaking clinical trials of drugs, devices, and combination products, and in the post marketing period.
- 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.
Requirements
What you’ll need- 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.
- 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- EEO & Accommodations as requested
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 analysissignal detectionaggregate report preparationsafety expertiseclinical trialspost marketing surveillancesafety regulationsmedical writingclinical medical monitoring
Soft Skills
client relationship developmentcommunicationteam collaborationpresentation skills
Certifications
MDDOboard certification