CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy)

CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy) University reputed company The reputed company, the largest private employer in Philadelphia, is a world-reputed company leader in education, research, and innovation. This historic, Ivy reputed company school consistently ranks among the top 10 universities in the annual reputed company survey. Penn has 12 highly-regarded schools that reputed company opportunities for undergraduate, graduate and continuing education, reputed company influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from reputed company who named Penn one of America's Best Large reputed company in 2023. Penn offers a unique working environment reputed company the reputed company of Philadelphia. 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Posted Job Title CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy) Job Profile Title Clinical Research Monitoring Specialist Senior Job reputed company reputed company The CRP Safety and Pharmacovigilance Manager plays a pivotal role in the Clinical Operations function by serving as an expert to reputed company for Cellular Immunotherapy (CCI) organization. The position facilitates reputed company improvement of CCI's proactive Serious Adverse Events (SAEs), Adverse Events (reputed company), Safety reporting and Safety Management processes and systems, including development of standards, processes, and training for clinical safety reputed company for reputed company 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 reputed company risks to CCI safety management in clinical trials, and develops mitigation strategies with the assistance of clinical operations and QA personnel Job reputed company Job Responsibilities ? reputed company Clinical Safety SOPs and Safety process Guide to Daily Operations ? Partner and reputed company with the Office of Clinical Research (OCR) on safety activities reputed company to the CCI clinical studies. ? Collaborate with the CCI Medical Director, Study Medical Directors, Study Project Managers, Clinical Sites and Scientists in CCI to reputed company clinical safety to ensure high standards of clinical trial conduct and analysis ? reputed company Safety Reports, Quarterly Safety Reviews, Investigator Notification, CCI IMV AE analysis reports and safety reports for IND/RAC Annual Reports and DSMB meetings. ? reputed company AE and SAE guidance and SAE reputed company training Qualifications Bachelors degree and 5 to 7 years of experience in Clinical Safety Management, Clinical Development and Operations, and/or Clinical reputed company Assurance or an equivalent combination of education and experience is required. ? RN preferred ? Experience in SOP and process design reputed company 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 reputed company to work reputed company reputed company under challenging and sometimes stressful conditions ? Exceptional knowledge of commonly-used clinical safety concepts, practices, and procedures reputed company GCP area ? Ability to work independently with minimal direction This position is contingent upon grant funding. Job Location - reputed company, State Philadelphia, reputed company Department / School Perelman School of Medicine Pay reputed company $61,046.00 - $92,148.00 Annual reputed company Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as reputed company as internal and market factors and grade profile. Affirmative reputed company Statement Penn adheres to a policy that prohibits discrimination on the reputed company of race, reputed company, sex, sexual orientation, gender identity, religion, creed, national or ethnic reputed company, citizenship status, age, disability, veteran status, or any other legally protect Apply tot his job Apply To this Job