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21 days old

Pharmacovigilance Clinical Program Manager - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814
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 VRCs 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 VRCs 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.





REQUIREMENTS: The contractor must have:




+ Clinical Advanced degree (NP, PA, MD, etc.) required.

+ 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.




**Why Kelly** **** **?**



Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.




**About Kelly** ****



Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law.

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Posted: 2020-11-11 Expires: 2020-12-12

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Pharmacovigilance Clinical Program Manager - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814

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