Provide medical safety expertise for clinical trials and post-marketing periods, including the medical review of adverse events. Responsible for preparing aggregate reports and performing signal detection and evaluation for global regulatory agencies.
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.
“I was the first applicant for a remote marketing position that got listed on the company website the same day I applied. Had an interview within 48 hours!”
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Marketing Manager
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