Kelly Government Solutions is seeking a Drug Safety Specialist at the National Institutes of Health (NIH) in Rockville, MD. This position will support a hybrid schedule.
This is a full-time, long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans.
- Paid leave (min 120 hours) as well as 11 paid federal holidays and 401K plan.
- Access to NIH's unparalleled resources and niche scientific initiatives.
- Learn more about what Kelly can do for you at
Position Overview:
Under this Task Order, the Contractor(s) shall provide services in support of the overall functions of the Safety and Pharmacovigilance Team in the Office for Policy in Clinical Research Operations, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID).
Technical Requirements:
- Ensure the most current domestic and international regulatory safety reporting requirements are used (e.g., ICH guidelines, FDA, EU and other national and international requirements). •
- Provide expert scientific and safety-related expertise to medical officers, study teams, and site investigators to include reviewing and providing comments to DAIDS medical officers on protocols and working with DAIDS medical officers to develop risk management/safety monitoring plans, as needed, for DAIDS-supported studies. •
- Serve as a subject matter expert on the safety reporting needed for new Clinical Trial Agreements, safety data exchange agreements, clinical materials transfer agreements and Communication plans
- Provide Expedited Adverse Event (EAE) reporting and safety management expertise and related safety support functions to include serving as a point of contact with project officers, contractors, grantees and intramural staff participating in both domestic and international studies and supporting the DAIDS Adverse Experience Reporting System (DAERS).
- Provide MedDRA coding expertise and support MedDRA-related activities.
- Develop and/or review a variety of safety-related documents and training materials for use by DAIDS, its CROs and partners (e.g., policies, procedures, work instructions, guidance, and training materials related to safety monitoring and reporting requirements for DAIDS-sponsored clinical trials).
- Provide advice in matters related to safety and pharmacovigilance which includes developing pharmacovigilance practices such as set-up and configuration of the safety database, signal detection, trend analysis, analysis of aggregate safety and adverse event data to identify safety concerns in Division-supported clinical trials and provide expertise in preparing reports related to the manufacturing of investigational products such as development safety update reports (DSUR).
Specific Qualifications:
- Minimum of a M.D. or Master's degree in health related field.
- Minimum of ten (10) years of related experience