CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy)

Job Description Summary

The CRP Safety and Pharmacovigilance Manager plays a pivotal role in the Clinical Operations function by serving as an expert to the Center for Cellular Immunotherapy (CCI) organization. The position facilitates continuous improvement of CCI's proactive Serious Adverse Events (SAEs), Adverse Events (AEs), Safety reporting and Safety Management processes and systems, including development of standards, processes, and training for clinical safety oversight for all CCI clinical trials. The Manager monitors adherence to regulatory requirements (ICH, FDA, NIH, NCI, etc.) and GCP guidelines, leads efforts to identify potential compliance and quality risks to CCI safety management in clinical trials, and develops mitigation strategies with the assistance of clinical operations and QA personnel

Job Responsibilities

• Develop Clinical Safety SOPs and Safety process Guide to Daily Operations
• Partner and interface with the Office of Clinical Research (OCR) on safety activities related to the CCI clinical studies.
• Collaborate with the CCI Medical Director, Study Medical Directors, Study Project Managers, Clinical Sites and Scientists in CCI to perform clinical safety to ensure high standards of clinical trial conduct and analysis
• Develop Safety Reports, Quarterly Safety Reviews, Investigator Notification, CCI IMV AE analysis reports and safety reports for IND/RAC Annual Reports and DSMB meetings.
• Provide AE and SAE guidance and SAE Form training

Qualifications

Bachelors degree and 5 to 7 years of experience in Clinical Safety Management, Clinical Development and Operations, and/or Clinical Quality Assurance or an equivalent combination of education and experience is required.

• RN preferred
• Experience in SOP and process design related to clinical safety management
• Extensive knowledge of FDA / global clinical trial regulations and ICH GCP Guidelines
• Understanding of the clinical development process and clinical safety documentation requirements
• Proactive approach to GCP clinical safety compliance
• Attention to detail, excellent communication skills and be able to work within a team under challenging and sometimes stressful conditions
• Exceptional knowledge of commonly-used clinical safety concepts, practices, and procedures within GCP area
• Ability to work independently with minimal direction

This position is contingent upon grant funding.