Principal

• Monitor the safety, quality, and efficacy of products marketed and sold by Par Health
• Receive, capture, and evaluate product feedback reports in accordance with FDA and global regulations and guidelines
• Provide technical and clinical information regarding product usage and performance
• Provide global Quality oversight for field alert reports, health hazard evaluations, and recalls
• Initiate and coordinate health hazard evaluations, field actions, and mock recalls
• Answer and triage incoming calls via the automatic call distribution line
• Review and approve customer complaint response letters
• Capture, review, and analyze customer usage reports
• Follow up on post-market customer usage and field service reports
• Evaluate complaints for potential adverse events and forward them to pharmacovigilance
• Collaborate globally on reports received from outside the US
• Conduct trend analyses of safety and efficacy profiles
• Prepare reports on continuing product performance for Quality and other departments
• Identify product performance issues and alert management
• Initiate and coordinate complaint investigations and support medical inquiries
• Ensure compliance with global product quality guidelines, standards, and regulations
• Oversee customer usage experiences, field feedback, product safety reporting, and professional consultation
• Collaborate with Legal, Regulatory Affairs, R&D, Commercial, Pharmacovigilance, Medical Information, Customer Service, and Manufacturing Sites
• Provide clinical and technical support for marketed pharmaceutical products
• Provide product performance expertise on cross-functional project teams
• Participate in product development and support teams
• Support audits and regulatory inspections
• Lead process improvement initiatives
• Train new hires, site personnel, and sales representatives on post-market reporting practices
• Report to the Manager, Product Monitoring
• Maintain frequent communication with customers, manufacturing QA personnel, Medical Information Specialists, and corporate divisions

Principal jobs in Missouri

Principal Product Surveillance Specialist