Associate Director, Pharmacovigilance Quality Assurance Auditor

The Associate Director, Pharmacovigilance Quality Assurance Auditor, is responsible for ensuring quality and compliance with local and international regulatory requirements by conducting audits of Organon Processes, Affiliates, Vendors, Business Partners, and Investigator sites.

Requirements

• Schedule and conduct assigned PV audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.
• Prepare audit reports and manage follow-up activities within established timelines.
• Maintain broad-based expertise in Organon Policies, Procedures and Guidelines, local and global regulatory requirements, etc., pertinent to GVP.
• Obtain and maintain cutting-edge knowledge, and application, for various Quality auditing topics.
• Generate and present comprehensive presentations/summary of audit issues for effective communication to all levels, as needed.
• Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet company and regulatory expectations.
• Supports the implementation and maintenance of the PV risk-based strategy, including assistance in the development of the annual audit plan and maintenance of the audit tool.
• Reviews and provides input into the quality sections of the Pharmacovigilance System Master File (PSMF).
• Supports regulatory inspections and external audits, when required.
• Train and mentor junior team members.

Benefits

• Annualized Salary Range
• Flexible Work Arrangements
• Shift
• Valid Driving License
• Hazardous Material(s)