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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.
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
medical reviewadverse event analysissignal detectionaggregate report preparationsafety expertiseclinical trialspost marketing surveillancesafety regulationsmedical writingclinical medical monitoring
Soft Skills
client relationship developmentcommunicationteam collaborationpresentation skills
Certifications & Qualifications
MDDOboard certification
Industry Keywords
drug safetydevice safetyglobal regulationspharmaceutical industrycontract research organizationquality assuranceregulatory affairsserious adverse eventsnon-serious adverse eventsperiodic adverse drug experience reports
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