Safety Surveillance Specialist (Clinical Research/Regulatory/PV)

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 DoW 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. ORA operates in a high-paced environment and seeks individuals who can work independently and take initiative in completing tasks

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

• 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.
• Experience with regulatory and pharmacovigilance
• Have excellent Microsoft Excel Spreadsheet skills.
• Excellent written and oral communication skills.
• Previous experience as an LPN, RN, study coordinator, or CRA/monitor preferred.
• Must be U.S. citizen and be able to obtain a NACI T1 (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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The likely salary range for this position is $97,968 - $105,800. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Scheduled Weekly Hours:

40 Travel Required

Less than 10% Telecommuting Options

Hybrid Work Location

USA MD Fort Detrick Additional Work Locations

Total Rewards at GDIT

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.Join our Talent Community to stay up to date on our career opportunities and events at gdit.com/tc .

Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans