Axle Informatics

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Job Locations US-MD-Bethesda
Axle Informatics is a bioinformatics and information technology company that offers innovative computer services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in software engineering, bioinformatics and program management, we focus on developing and applying technology tools and techniques to empower decision-making and accelerate the discovery in translational research. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail oriented Pharmacovigilance Clinical Program Manager to join our vibrant team at Bethesda, MD.   Responsibilities  - 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.    Experience Required / Requirements   - Clinical Advanced degree (NP, PA, MD, etc.) is required.  - Minimum 3 -5 years’ experience in PV with significant experience in preparing regulatory documents.   - 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.   - Minimum of 5 to 10 years’ related experience in a biotechnology, pharmaceutical company, government, 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 required  - An 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.    Benefits - Paid Time Off (PTO) - 10 Paid Federal holidays - Various wellness programs - Employee Referral Bonus Program (ERBP) - Vision coverage through Cigna national network - Dental coverage through Cigna national network - 401(K) with significant company match & no vesting period - Short and Long-Term Disability coverage (paid by company) - Competitive salaries with opportunity for performance bonuses - Discount plan for pet care, legal services, & identify theft protection - Basic Life and AD&D coverage (paid by company; option to purchase additional coverage) - Medical coverage through UHC national network (option to choose between 3 available plans) - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN)   The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.      Accessibility: If you need an accommodation as part of the employment process please contact:                       Email:   Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.