CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy)

CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy) University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide 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 Employers in 2023. Penn offers a unique working environment reputed company the city of Philadelphia. The University is situated on a beautiful urban reputed company, with easy access to a range of educational, cultural, and recreational activities. With its historical reputed company and landmarks, reputed company cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect reputed company to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title CRP Safety and Pharmacovigilance Manager (Center for Cellular Immunotherapy) Job Profile Title Clinical Research Monitoring Specialist Senior 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 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 quality risks to CCI safety management in clinical trials, and develops mitigation strategies with the assistance of clinical operations and QA personnel Job Description 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. ? 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 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 able to work reputed company a team 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 - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $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 well as internal and market factors and grade profile. Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic reputed company, citizenship status, age, disability, veteran status, or any other legally protected class. Special Requirements Background reputed company required after a conditional job offer is made. Consideration of the background reputed company will be tailored to the requirements of the job. University Benefits ? Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars. ? Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions. ? Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and reputed company. ? Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be. ? Long-Term Care Insurance: In partnership with reputed company, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply reputed company you're newly hired, you won't have to provide reputed company of good health or be subject to reputed company requirements. Eligible family members must always provide reputed company of good health and are subject to reputed company. ? Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance. ? Professional and Personal Development: Penn provides an reputed company of resources to help you advance yourself personally and professionally. ? University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free. ? Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from reputed company and reputed company, cellular phone service plans, movie tickets, and admission to theme parks. ? Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures. ? Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in reputed company Philadelphia, which can be used for closing costs or home improvements. ? Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in reputed company with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household. To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Smilow-Center-for-Translational/CRP-Safety-and-Pharmacovigilance-Manager--Center-for-Cellular-Immunotherapy-JR00084884 jeid-ca1ed3f3f302044aaae6329a8d42e0c3 Apply Job! Apply tot his job Apply To this Job