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

Under general direction, the Senior Complaint Investigator, Post Market Compliance (PMC) is responsible for managing post-market compliance reporting for Aveva’s products from consumers, marketing partners, and other sources, related to product quality complaints or product quality inquiries.  This includes responsibility for leading the work scheduling of the PMC group, review and approval of technical complaint cases, and training of the PMC personnel.  The Senior PMC Investigator is responsible for ensuring compliance of technical complaints with regulatory requirements (i.e. US Food and Drug Administration (FDA), Health Canada, and other Regulatory Agencies as required).

The Senior Complaint Investigator PMCs responsible for daily, weekly, and monthly tracking and trending reports of complaints to Aveva Management (Quality Council) and as appropriate, to partners/clients, and regulatory agencies.  The Senior Investigator is responsible for the timely initiation, investigation, documentation, and management of customer complaints including multidisciplinary investigations required in support of complaints, maintaining required cycle times and ensuring a validated customer complaints database is maintained and upgraded in compliance with FDA rules, regulations, and expectation.

The Senior Complaint Investigator PMCs is responsible for the compilation of the Annual Product Reviews (APRs) for the commercial products manufactured at Aveva, ensuring the Executive Summary is written, and the APRs approved within the required timeframes.

Key Responsibilities

• Manages the complaint handling reporting system, including interacting with management, partners, contractors, and regulatory agencies. 
• Oversee the schedule and allocation of PMC resources to ensure customer complaints are initiated, investigated, reported, responded to, and approved in an efficient and compliant manner.
• Ensures all critical investigations that have potential market impact follows the internal escalation procedure.
• Conducts the initiation, investigation, documentation, and management of customer complaints including multidisciplinary investigations required in support of complaints.
• Evaluates and approves complaint investigations; ensures multidisciplinary investigations are initiated and completed per requirements.
• Recognize critical path for complaint investigations and provide timely support to lead investigators to identify appropriate Subject Matter Experts, root cause, corrective & preventative actions.
• Writes 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 to upper management at Aveva through the Quality Council and through Annual Product Reviews.
• Responsible for timely submission of Periodic Reports, Annual Reports, and other submissions as assigned for Aveva-owned marketing applications to management.
• Participate 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 support of our Values: Collaboration, Courage, Perseverance, and Passion.
• All other relevant duties as assigned.

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