GDIT’s Military Health team is hiring a Safety Surveillance Specialist to support the Office of Regulated Activities (ORA), United States Army Medical Research and Development Command (USAMRDC) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.
The Office 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 provides full-service, oversight, and consultation for 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.
HOW YOU WILL MAKE AN IMPACT:
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
WHAT YOU’LL NEED TO SUCCEED:
Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
8+ 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.
Location: Onsite Ft Detrick, some remote but local in the area
US Citizenship Required: Must be U.S. citizen and be able to obtain a TI (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
GDIT is an Equal Opportunity/Affirmative Action employer.
On the frontlines of health innovation.We lead the technology, systems and research that drive better health. Because health agency missions have real life outcomes – providing access to care, advancing medical research and enhancing lives.From deploying one of the largest clouds in the federal government, to detecting fraud, waste and abuse to protect the Medicare trust fund, researching new breakthroughs in treating traumatic brain injuries and connecting veterans with benefits they have earned.GDIT is there. On the ground. In the lab. And on the frontlines of health IT.