General Dynamics (GDIT) Military Health team is looking for a Safety Surveillance Specialist to join our team to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.TheOffice of Regulated Activities (ORA)is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA providesfull-service, oversight,andconsultationfor regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.

The position is located in Frederick, Maryland. It is a hybrid role, and you would be required to be on-site 2-3 days/week.

• Develop pre-market and post market safety surveillance plan(s) specific to products/protocols that include signal detection tools and templates necessary to implement the safety surveillance
• Develop and maintain safety management plan(s) that delineate the roles, responsibilities, processes, and timelines for safety activities and drives the execution of the safety related activities during a trial
• Establish Data Safety Monitoring Boards/Committees, which includes identifying members, developing, reviewing and finalizing the initial Charter and any revisions
• Schedule and coordinate Data Safety Monitoring Board/Committee Meetings (organizational, in-process, executive, and ad hoc), including a face to face initial data safety monitoring board/committee organizational meeting at a central location within the continental United States, and provide an agenda
• Receive, process, evaluate, and manage reported safety cases through electronic systems which may include but are not limited to data entry and preparation of serious adverse event narratives, generating analyses of similar events, data element coding of event terms in the safety database utilizing the Medical Dictionary for Regulatory Activities and preforming quality control reviews of the entered data
• Monitor the safety mailbox for new incoming unexpected and related serious adverse events
• Triage safety reports, interpret clinical data, and perform regulatory evaluation for regulatory reporting purposes
• Track follow-up information /correspondence through to case closure
• Notify the investigator(s) of safety information, including expedited serious adverse events, according to Government procedures and in accordance with 21 CFR 312.32 and 312.33 and ICH Guidelines
• Develop and/or review protocol specific documents and clinical safety documents including but not limited to clinical protocols, informed consent forms, investigator brochures, data monitoring committee charters, safety management plans, safety surveillance plans, safety-related source document and other associated clinical safety documents

REQUIRED QUALIFICATIONS

• Bachelors Degree or the equivalent combination of education, professional training, or work experience.
• + years of related experience - clinical drug safety, FDA regulations
• Must be highly organized, detail oriented, and perform independently.
• Have excellent Microsoft Excel Spreadsheet skills.
• Excellent written and oral communication skills.
• Must be U.S. citizen and be able to obtain a NACT3 (Public Trust) clearance.

WHAT GDIT CAN OFFER YOU:

• Challenging work that makes a real impact on the world around you
• Internal mobility team dedicated to helping you own your career
• 401K with company match
• Diverse, highly collaborative teams
• Professional development, education assistance, certification and training opportunities

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