Staff
2012 CSL Behring L.L.C. · King of Prussia, Pennsylvania
Apply on 2012 CSL Behring L.L.C.'s site →Goes straight to the employer's own hiring page. We never sit in between.
Plan and execute pharmacovigilance audits of external vendors and internal safety processes and report findings.
Worth knowing: Role requires up to 50% travel
The Opportunity: Quality in a globalized drug safety network is a matter of operational resilience as much as regulatory mandate. This role serves as a GVP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of safety data and compliance with legal and corporate standards. By conducting audits of our external partners and internal safety functions, you identify the findings and non-compliance trends that could impact the reliability of our pharmacovigilance system. We are looking for an experienced auditor who can navigate complex safety environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability. Main Responsibilities Audit Execution: Conduct assigned external audits of pharmacovigilance vendors and service providers, as well as internal self-inspections of safety processes, systems, and affiliates (including Local/Regional Safety Officers (LSO/RSOs) activities). Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to drug safety. Trend Analysis: Identify non-compliance trends and systematic risks within the PV discipline, communicating these findings to line management and functional leads to support PV system health and protect the integrity of the PSMF documenting it. Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions that ensure compliance with EMA Guidelines on Good Pharmacovigilance Practices (GVP Modules), and applicable global and local regulatory requirements.. Regulatory Knowledge: Maintain up-to-date knowledge of global GVP regulations (Good Pharmacovigilance Practices) and industry trends, to support internal quality and compliance. Position Qualifications & Experience Academic Background: BS degree in a relevant biological science, pharmacy, or related science discipline. Professional Experience: Quality Assurance experience within a GVP-regulated environment, demonstrating a strong understanding of drug safety operations and regulatory frameworks.
Pay, CPA exam support and hiring patterns at 2012 CSL Behring L.L.C.
All open 2012 CSL Behring L.L.C. jobs on this board
Every job links to the employer's own site. This job board is free: no ads, no account.