Senior Compliant Investigator, PMC

About Us: Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide. Job Summary: The Senior PMC Investigator is responsible for daily, weekly, and monthly tracking and trending reports of complaints, to support reporting to Aveva Management (Quality Council) as appropriate, and communication to partners/clients, and regulatory agencies. The Senior Investigator is responsible for the timely initiation and for conducting multidisciplinary investigations required in support of complaints, maintaining required cycle times and documenting the investigation results using a validated customer complaints database in compliance with FDA rules, regulations, and expectation. The Senior Investigator supports the compilation of the Annual Product Reviews (APRs) for the commercial products manufactured at Aveva within the required APRs process timelines. Key Responsibilities: Manages the complaint handling reporting system, including interacting with management, partners, contractors, and regulatory agencies. Ensures all critical investigations that have potential market impact following the internal escalation procedure. Conducts complaint investigations; ensures multidisciplinary investigations are initiated and completed per requirements Recognizes critical path for complaint investigations and liaises with appropriate Subject Matter Experts to ensure timely support to complaint investigations to identify, root cause, corrective & preventative actions. Maintains compliance with procedures and reports, performs weekly, monthly, and other periodic exchanges per regulatory requirements and agreements to ensure compliance with reconciliation requirements for complaints Analyzes data and reports trends in quality systems and communicate to management team as required. Supports timely submission of Periodic Reports, Annual Reports, and other submissions as assigned for Aveva-owned marketing applications to management Participates in inspections by regulatory agencies and auditors, and can serve as primary contact or inspection team coordinator Works as a member of a team to achieve all outcomes Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements; All other duties as assigned