- 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
- 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
- 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 Vanguard.
- 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 Genworth Financial, 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 when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
- 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 array 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 Ford and General Motors, 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 West Philadelphia, which can be used for closing costs or home improvements.
- Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
-
Madrigal Pharmaceuticals Corporation Conshohocken, United StatesJob Description · Job DescriptionReporting to the Associate Director, Postmarketing Pharmacovigilance or higher, the Senior Manager, Postmarketing Pharmacovigilance will play a key role in supporting the safety assessment, evaluation, and risk management of products in the postma ...
-
Madrigal Pharmaceuticals Corporation Conshohocken, United StatesJob Description · Job DescriptionThis position will play a key role in supporting the safety assessment, evaluation and risk management of products in various stages of development as well as involvement in safety surveillance activities. · This position reports into the VP, Phar ...
-
Director, Us
2 weeks ago
GSK Philadelphia, United States**Site Name**: USA - Pennsylvania - Philadelphia · **Posted Date**: May · The **Director, US & Regions Intelligence Oversight, Pharmacovigilance (PV) Operations** serves as the first point of contact for PV Regulatory intelligence (PVRI), issues and escalations across US & Regio ...
-
Pharmaron Exton, United StatesJob Description · Job DescriptionThe Role: · The Pharmacovigilance (PV) Project Management Manager/Senior Manager will be a key member of the PV Project management Team in US managing PV projects independently, and making appropriate processes for the project according to regulat ...
-
Pharmaron Exton, United StatesJob Description · Job Description · The Role: · The Pharmacovigilance (PV) Project Management Manager/Senior Manager will be a key member of the PV Project management Team in US managing PV projects independently, and making appropriate processes for the project according to regu ...
-
Associate Director Pharmacovigilance Safety
3 weeks ago
Spark Therapeutics Philadelphia, United StatesJoin the Spark Team · We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. · We don't follow foo ...
-
Exelixis King of Prussia, United StatesReference #: JR5530 SUMMARY/JOB PURPOSE: · The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables (eg safety surveillance) for assigned project(s). The role col ...
-
Director, US
1 week ago
GSK Philadelphia, United StatesThe Director, US & Regions Intelligence Oversight, Pharmacovigilance (PV) Operations serves as the first point of contact for PV Regulatory intelligence (PVRI), issues and escalations across US & Regional PV Operations, Global Safety (183 country remit). The role will include lia ...
-
Power BI Developer
2 weeks ago
NR Consulting Philadelphia, United StatesRole: Power BI Developer · Location : Philadelphia P · Job Description · - 3-5 years of experience in Power BI report development. · - Proven experience in assisting with business analysis and troubleshooting. · - Good problem-solving, communication, and teamwork skills. · - B ...
-
Business Development Associate
2 weeks ago
ACL Digital Philadelphia, United StatesWe seek a highly skilled Associate Business DevelopmentManager with the drive and determination to help us expand our client base. This position reports to our Director of Sales and Marketing. In addition, as the business development lead, my responsibilities include coordinating ...
-
Clinical Operations Lead
2 weeks ago
Incyte Corporation Wilmington, United StatesOverview: · Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and develop ...
-
Spark Therapeutics Philadelphia, United StatesJoin the Spark Team · We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. · We don't follow foo ...
-
Business Development Associate
3 weeks ago
ACL Digital Philadelphia, United StatesWe seek a highly skilled Associate Business DevelopmentManager with the drive and determination to help us expand our client base. This position reports to our Director of Sales and Marketing. In addition, as the business development lead, my responsibilities include coordinating ...
-
Bristol Myers Squibb Philadelphia, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Medical Science Liaison, Neurology
3 weeks ago
Bristol-Myers Squibb Philadelphia, PA, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Director, Safety Surveillance Physician
1 week ago
Johnson & Johnson Horsham, United StatesJohnson & Johnson, is recruiting for a **Director, Safety Surveillance Physician (Oncology) **to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA. · We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of ...
-
Sr. Dir., Associate General Counsel
2 weeks ago
Spark Therapeutics Philadelphia, United StatesJoin the Spark Team · We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. · We don't follow foo ...
-
Director, Medical Safety Officer, Oncology
3 days ago
Johnson & Johnson Horsham, United StatesJohnson & Johnson, is recruiting for a Director, Medical Safety Officer, Oncology to be located in Horsham, PA; Titusville, NJ; or Raritan, NJ. · We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in ...
-
Bristol Myers Squibb Philadelphia, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Vp, Regional Medical Officer
3 days ago
Thermo Fisher Scientific Wilmington, United StatesSummarized Purpose: · Serves as the Regional Medical Officer for PPD Biotech. · Focuses on business development and client engagement and sustained relationship efforts for Biotech West Coast Region. Delivers strategic value to Biotech clients from an industry experienced medical ...
CRP Safety and Pharmacovigilance Manager - Philadelphia, United States - InsideHigherEd
Description
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, all 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 Forbes who named Penn one of America's Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place 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 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 Description
Job Responsibilities
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.
This position is contingent upon grant funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$61, $92,148.00 Annual Rate
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 origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
To learn more, please visit:
To apply, visit
Copyright 2022 Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
jeid-9bfb17040c0ecc4a92025babbe8f8540
CRP Safety and Pharmacovigilance Manager professionals in Philadelphia
-
Mason Hall
Lifeguard/Swim Instructor
-
Joanna Hecker
Operations Leader | Strategic Team Builder
-
Nathan Luce
Healthcare Administrator
-
Daniel Thompson
Graduate Biology Student
-
Bianca Mussie
receptionist
-
Dorothy Pierre
Canvass Team Lead for Planned Parenthood Canvass