SAFETY MANAGER

Location
Philadelphia
Posted
Mar 24, 2018
Administrative Jobs
Academic Affairs
Institution Type
Four-Year Institution

Duties: The Center of Cellular Immunotherapies is seeking a Safety Manager. This position will be responsible for preparation of safety data that will be included in the safety reports utilized for reporting safety committees (FDA, NIH-OSP, DSMB) and safety evaluation/analysis of novel Phase I gene therapy clinical trials conducted by the Center for Cellular Immunotherapies. Conduct of quality control (QC) and quality assurance (QA) procedures of the clinical database to ensure complete and accurate accounting of all safety data used for reporting purposes such as but not limited to, reporting to FDA, NIH - OSP, DSMB, Investigator Notifications (IN) and for updating the Investigator Brochure (IB). Process safety reports, safety queries, CAPA's and implement correction actions to ensure safety reporting compliance

Qualifications: A Bachelor's Degree and 3 to 5 years of experience or equivalent combination of education and experience required.
* Good understanding of clinical research required
* Good understanding of Adverse Events and Serious Adverse Events required
* Previous experience with Immunotherapy trials in cancer research or at a minimum has previously worked in cancer research
o Identification of AE/SAE's in clinical source documents required
o Previous experience with Velos database or any database where they create data outputs for reports
o Must be detail oriented

Reference Number: 40-28255

Salary Grade: 027

Employment Type: Exempt

Org: CI-Center for Cellular Immunotherapy

Special Requirements:

Job Family: B-Executive/Managerial Administration

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