Posted:1 month ago|
Platform:
Work from Office
Full Time
Support in the implementation of a compliant quality management system for Clinical trials. Monitor the quality compliance of Clinical Trials, Bioavailability and Bioequivalence Organization. Compliance review and identifying process improvement/ optimization in Pharmacovigilance (PV) and Clinical operations. Providing support to the Medical Affairs with respect to interpretation of regulatory guidelines. Responsible to feed information into the tracking tool to be able to provide trends on compliance reviews. Assist in preparation, review of standard operating procedures for Clinical Trials, BA/BE and PV Support in quality control reviews of key trial documents (protocols, Informed Consent forms, Clinical Study Reports, Investigator Brochures, and others if requested). Perform quality control review of the PV processes like ICSR, Aggregate report and Signal report. Support in external and internal audit preparation activities during audit. Support in risk management for Medical Affairs function related activities. Support in implementation and ensuring compliance to ISO 27001 and ISO 27701 standards.
Arcolab
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