Kelly Government 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 offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Pharmacovigilance Clinical Program Manager to work onsite with the National Institutes of Health in Bethesda, MD.
This is a long-term contract position which offers:
- Competitive salary with comprehensive benefit package
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com
TASKS: The contractor shall:
Oversee all aspects of the VRC CTP Pharmacovigilance Program, which leads the process for safety signal management activities, and ensure the detection, assessment, understanding and prevention of safety events for each investigational product (IP) the VRC manufactures for clinical research.
Provide tactical leadership for the VRC CTP Pharmacovigilance Program/Team.
Create and adapt pharmacovigilance procedures based on prevailing domestic and international regulations, VRC polices/procedures, etc.
Review safety events for completeness and trends; analyze comprehensive safety data in consultation with PV team; communicate findings to VRC’s Office of Regulatory Sciences.
Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines.
Draft, review and finalize PV data agreements with collaborators who receive VRC-manufactured investigational products.
Work with VRC’s external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).
Author/provide strategic input or oversight for PV related sections of periodic regulatory documents (i.e. IND annual reports, DSURs, IB updates) according to the agreed process and timelines.
Monitor and evaluate safety profiles of VRC manufactured investigational products to detect any change in risk profile.
Collaborate with VRC CTP protocol operations, medical, quality and risk management teams to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.
Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.
Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.
Minimum of 5+ years’ experience in Pharmacovigilance with significant experience in preparing regulatory documents in a biotechnology, pharmaceutical company, government, or CRO environment..
Knowledge of clinical trial and PV methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements in PV.
Experience with MedDRA and drug coding reviews.
Strong experience in the conduct and management of clinical trials, especially phase I – III vaccine or monoclonal antibody clinical trials.
Strong background in clinical trial drug safety is required.
Understanding of medical terminology and ability to summarize medical information is required.
Personnel management experience required.
Strong attention to detail and follow-up skills required.
Must be flexible and willing to take on significant administrative responsibilities.
Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed.
Must be able to create contingency plans to deal with possible challenges and roadblocks.
Good computer and database skills, familiarity with ARGUS platform is preferred.
Experience in MS Office including; Word, Excel, Outlook, PowerPoint.
Strong communication skills, both oral and written.
Excellent analytical, organizational, and time management skills.
PLEASE APPLY ONLINE
Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.
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