Lead, and/or conduct/support (in collaboration with GMP QA colleagues), global Good Pharmacovigilance Practice (GVP) Audits of systems and processes related to clinical and post-market patient safety information collection, evaluation and reporting.
March 13, 2020
Demonstrated ability to apply comprehensive, in-depth, understanding of pharmaceutical industry regulatory compliance requirements with an emphasis on GMP/GLP/GCP related issues, and related US and international laws.
April 19, 2020
Participate in the development of internal and external GLC/GCP/GVP annual audit plan for sites and vendors and update the audit plan as needed based on identified risks and trial priorities.
April 23, 2020
Manage batch release activities for clinical production including but not limited to review of batch records, analytical data with emphasis on the effect of safety and/or efficacy impact to the clinical study, certificates of analysis, evaluation of the IND and other documents.
April 29, 2020
Support process transfer and process engineering of retroviral replicating vectors (RRV) platform products including process optimization, new product implementation, process transfer, scale-up, validation, risk analysis process characterization and troubleshooting.
June 05, 2020
Review and approve SOPs, Mater Batch Records, test methods, test results, labeling materials, specifications, analytical validation protocols and reports, and stability protocols and reports and associated records/data.
June 08, 2020
Collaborate with Commercial, IT, Clinical Operations and Supply Chain to execute and improve processes that include the interlinked process elements of patient identification, treatment regimen and logistics.
June 11, 2020