Kelly Government Solutions is seeking an experienced individual to work as a Safety and Pharmacovigilance Advisor at the National Institutes of Health in Rockville, MD. Position is estimated to support a hybrid work arrangement that involves on-site work (likely 1 day/week) at the NIH in Rockville, MD.
This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
- Paid leave, paid federal holidays, and 401K plan.
- Access to NIH’s unparalleled resources and niche scientific initiatives
KEY TASKS
(1) 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).
(2) Provide expert scientific and safety-related expertise to medical officers, study teams, and site investigators to include reviewing and providing comments to Division of AIDS (DAIDS) medical officers on protocols and working with DAIDS medical officers to develop risk management/safety monitoring plans, as needed, for DAIDS-supported studies.
(3) 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
(4) 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).
(5) Provide MedDRA coding expertise and support MedDRA-related activities.
(6) 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).
(7) Provide advice in matters related to safety and pharmacovigilance and 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).
KEY REQUIREMENTS
(1) MD degree; master’s or Ph.D. degree in a health-related field with relevant experience may also be considered
(2) Minimum of ten (10) years of related safety and pharmacovigilance experience.
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