Clinical Quality Assurance Manager and Pharmacovigilance Coordinator (CQAM&PHVC)

Updated: March 22, 2024 12:54 AM GMT

Full-time Job in Lainate, Lombardy

Cosmo Pharmaceuticals

Lainate, Metropolitan City of Milan

As Clinical Quality Assurance will have the following responsibilities for Cosmo group companies performing clinical operations (clinical trials):

· To provide advice, guidance to stakeholders on Quality, Safety & Environment related topics based on standards, regulatory requirements, code of practices, guidelines and technical requirements.

· To develop and maintain ICH-GCP related quality system SOPs and proactively provide ICH-GCP support for clinical development activities in compliance with all applicable regulatory requirements, aligning with existing company policy.

· To manage preparation activities to health authorities inspections, participate and provide leadership and oversight ensuring timely, relevant, and accurate corporate responses to queries and/or findings.

· To assess the ongoing state of regulatory preparedness and ensure inspection readiness by developing an audit program, applicable assessments, and other surveillance efforts of internal and external teams... More Detail