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Manager, PV Quality Issue Management

5 - 9 years

0 Lacs

hyderabad telangana

Posted:2 weeks ago| Platform: Shine logo

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Skills Required

pharmacovigilance quality management system deviation management risk assessment compliance quality analysis gvp audits capa management

Work Mode

On-site

Job Type

Full Time

Job Description

As a Patient Safety Support Manager, your primary responsibility will be to manage the outcomes of various audits related to Pharmacovigilance (GVP) systems and processes. This includes overseeing internal audits, business partner audits, deviation investigations, and providing support for the PV Quality Management System (QMS). Your duties and responsibilities will involve ensuring that corrective and preventative actions are promptly authored and implemented following post-evaluation of GVP audits. You will collaborate effectively with external quality and compliance organizations to uphold high standards of quality within the department. In addition, you will participate in or lead assessments to identify, assess risks, investigate, and close GVP deviations affecting the system. You will also contribute to suggested remediation efforts and monitor CAPA, Effectiveness Check, Deviation, and associated risk triggers for reporting to the PV Quality Council and functional management. Furthermore, you will be responsible for analyzing quality issues from various sources, summarizing the results effectively, and communicating with stakeholders to address and prevent recurrence of compliance issues. You will play a key role in suggesting improvements to departmental standard operating procedures related to CAPA management, effectiveness checks, deviation management, and GVP QMS. As part of the PV Compliance and Quality Risk Management team, you will collaborate with internal stakeholders to align with GVP QMS principles regarding CAPA management, effectiveness checks, and deviation management. It will also be essential to ensure that all data supporting deviations and open CAPA in the Pharmacovigilance System Masterfile (PSMF) is up-to-date and of high quality. Overall, your role will be crucial in maintaining the integrity of the Patient Safety support function by overseeing audits, managing deviations, and contributing to continuous improvement efforts in compliance and quality within the Pharmacovigilance system.,

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