Clinical Advisor-Pharmacovigilance: NIAID VRC/CTP

Company: CAMRIS International
Location: Bethesda
Posted on: September 8, 2020

Job Description:

OverviewCAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world.--Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!CAMRIS--is seeking a Clinical Advisor to support the mission of--the--National Institute of Allergy and Infectious Diseases (NIAID) at The National Institutes of Health (NIH) by--conducting and supporting basic, translational and clinical research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.--The Clinical Advisor will provide the following services in support of Vaccine Research Center/Clinicla Trials Program, including:--ResponsibilitiesOversee 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 issues 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.QualificationsClinical Advanced degree (NP, PA, MD, etc.)Minimum 3 -5 years' experience in Pharmcovigilance with significant experience in preparing--regulatory documents.Knowledge of clinical trial and Pharmcovigilance methodologies including safety profile and--risk/benefit analysis and detailed comprehension of global regulatory requirements in Pharmcovigilance.Experience with MedDRA and drug coding reviews.5 to 10 years' related experience in a biotechnology, pharmaceutical company, goverment, or CRO environment 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--requiredAn understanding of medical terminology and ability to summarize medical information is--required.Personnel management experience is required.Strong attention to detail and follow-up skills is 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. Job Summary# of Openings: 1Category: OtherType: Regular Full-Time

Keywords: CAMRIS International, Bethesda , Clinical Advisor-Pharmacovigilance: NIAID VRC/CTP, Healthcare , Bethesda, Maryland