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.This position is based in the Ft. Detrick and Frederick, Maryland.Duties include:
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
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.
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
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.