Description
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are 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
TASKS/SERVICES. The contractor shall:
(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).
REQUIREMENTS. The contractor must have:
(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.
PLEASE APPLY ONLINE
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren't contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, short-term disability, and a transportation spending account.
Visit https://www.mykelly.us/us-mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Government Solutions?
Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the world's most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It's just another way we make the job search work for you.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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