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General Dynamics Information Technology · 3 days ago

Safety Surveillance Specialist (Clinical Research)

USA MD Fort Detrick

Full-time

Hybrid

Mid, Senior Level

$98K/yr - $106K/yr

5+ years exp

General Dynamics Information Technology is seeking a Safety Surveillance Specialist to support the Office of Regulated Activities under the DoD at Ft. Detrick, Maryland. The role involves developing safety surveillance plans, managing safety cases, and ensuring compliance with regulatory requirements for FDA-regulated products.

Artificial Intelligence (AI)Cloud ComputingConsultingCyber SecurityInformation Technology

No H1B

U.S. Citizen Only

Responsibilities

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

Qualification

Clinical SafetySafety ReportingSurveillanceFDA regulationsMicrosoft ExcelCommunicationDetail orientedOrganizational skills

Required

Bachelor's Degree or the equivalent combination of education, professional training, or work experience

5 + 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

Benefits

401K with company match

A variety of medical plan options, some with Health Savings Accounts

Dental plan options

A vision plan

The ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match

Full flex work weeks where possible

A variety of 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

Company

General Dynamics Information Technology

Glassdoor3.9

General Dynamics Information Technology is an IT consulting company that specializes in cyber security, AI, and quantum computing. It is a sub-organization of General Dynamics.

Founded in 1999

Falls Church, Virginia, USA

10001+ employees