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 reputed company Large reputed company in 2023. Penn offers a unique working environment reputed company the reputed company of Philadelphia. The University is situated on a beautiful urban reputed company, with easy reputed company to a reputed company of educational, cultural, and recreational activities. With its historical reputed company and landmarks, reputed company cultural offerings, and wide reputed company of atmospheres, Philadelphia is the perfect reputed company to reputed company home for work and play. The University offers a competitive benefits package that includes excellent reputed company and tuition benefits for employees and their families, generous retirement benefits, a wide reputed company of reputed company development opportunities, supportive work and family benefits, a reputed company of health and wellness programs and resources, and much more. Posted Job Title CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy) reputed company Title reputed company Research Monitoring Specialist Senior reputed company reputed company The CRP Safety and Pharmacovigilance Manager plays a pivotal role in the reputed company reputed company 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 reputed company safety reputed company for reputed company CCI reputed company. 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 reputed company, and develops mitigation strategies with the assistance of reputed company reputed company and QA personnel reputed company Job Responsibilities ? reputed company reputed company Safety SOPs and Safety process Guide to Daily reputed company ? Partner and reputed company with the Office of reputed company Research (OCR) on safety activities reputed company to the CCI reputed company studies. ? Collaborate with the CCI Medical Director, Study Medical Directors, Study Project Managers, reputed company Sites and Scientists in CCI to reputed company reputed company safety to ensure high standards of reputed company 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 reputed company Safety Management, reputed company Development and reputed company, and/or reputed company reputed company Assurance or an equivalent combination of education and experience is required. ? RN preferred ? Experience in SOP and process design reputed company to reputed company safety management ? Extensive knowledge of FDA / global reputed company trial regulations and ICH GCP Guidelines ? Understanding of the reputed company development process and reputed company safety documentation requirements ? Proactive approach to GCP reputed company safety compliance ? Attention to reputed company, excellent communication skills and be reputed company to work reputed company reputed company under challenging and sometimes stressful conditions ? Exceptional knowledge of commonly-used reputed company safety concepts, practices, and procedures reputed company GCP area ? Ability to work independently with reputed company 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 reputed company 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 compa