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Scientific Program Manager (Pharmacovigilance)
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Full-time
- Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), Vaccine Research Center (VRC), Clinical Trials Program (CTP).
- Oversee operational aspects of the VRC Clinical Trials Program (CTP) Pharmacovigilance (PV) Team, which leads the process for safety signal management activities, and ensures the detection, assessment, understanding and prevention of safety events for each investigational product (IP) the VRC manufactures for clinical research.
- Create and adapt drug safety and pharmacovigilance procedures based on prevailing domestic and international regulations and VRC/NIAID policies and procedures.
- Collaborate with CTP protocol operations, clinical and quality and risk management teams, as well as the VRC Regulatory and Strategic Planning groups, to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.
- Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.
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