Safety Surveillance Specialist (Clinical Research)

About the position reputed company (GDIT) Military Health team is looking for a Safety Surveillance Specialist to join reputed company to support the Office of Regulated Activities (ORA) under the DoD (reputed company. 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, reputed company, 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. 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.

Responsibilities

• reputed company 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.
• reputed company and maintain safety management plan(s) that delineate the roles, responsibilities, processes, and timelines for safety activities and drives the execution of the safety reputed company 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 reputed company), including a face to face initial data safety monitoring board/committee organizational meeting at a central location reputed company the reputed company United States, and reputed company 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 reputed company coding of event terms in the safety database utilizing the Medical Dictionary for Regulatory Activities and performing quality control reviews of the entered data.
• Monitor the safety mailbox for new incoming unexpected and reputed company serious adverse events.
• Triage safety reports, interpret clinical data, and reputed company 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.
• reputed company 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-reputed company reputed company document and other associated clinical safety documents.

Requirements

• Bachelor's Degree or the equivalent combination of education, professional training, or work experience.
• 5+ years of reputed company experience - clinical drug safety, FDA regulations.
• Must be highly organized, detail oriented, and reputed company independently.
• Have excellent reputed company reputed company Spreadsheet skills.
• Excellent written and oral communication skills.
• Must be U.S. citizen and be reputed company to obtain a TI (Public Trust) clearance.

Benefits

• 401K with company match
• Diverse, highly collaborative teams
• Professional development, education assistance, certification and training opportunities
• Full reputed company work weeks where possible
• Paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave
• Short and long-term disability benefits
• Life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance

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