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- This position is responsible for handling Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics and combination products.
- Knowledge of regulatory requirements, GMP, GDP, quality & compliance and complaint handling is required.
- Maintains onsite sample room and mailroom as per departmental SOP.
- Responsibilities
- Understands the importance of data entry of complaints within the required timeframe.
- Understands special details for handling each product within the department.
- Understands departmental process flow on drug and device complaints.
- Proficient with use of all databases within the department (ie. ACES-Siebel, Global PTC Database, Microsoft Office).
- Prepares appropriate correspondence for complaints.
- Identifies and prepares appropriate mailers for use in retrieving the complaint samples.
- Produces daily reports for follow-up activity.
- Reviews and processes reconciliation with Pharmacovigilance.
- Process complaint samples upon receipt
- Identifies and handles lot discrepancies correctly with returned complaint samples.
- Understands export shipping requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.
- Identifies and prepares complaint samples for shipping to manufacturing sites.
- Orders departmental supplies.
- Identifies complaints for field alert reporting
- Performs QC Checks
- Provide customer service to consumers, health care professionals, and internal/external departments regarding individual complaints.
- Provide support to US Product Quality Complaint Managers/Director during audits by FDA, other regulatory agencies, third parties and internal groups.
- Notifies interested departments (including manufacturing sites QA, commercial, regulatory, supply chain) upon receipt of complaints.
- Understands the FDA complaints regulations for the drug products and medical devices.
- Maintains monthly reports as needed
- Provide complaints support to other company departments including but not limited to customer service, medical information, Pharmacovigilance, sales associates, regulatory, commercial operations, legal, and risk management
- Maintains sample room and mailroom as per departmental SOP.
- Associate degree with minimum 2-3 years of experience in a pharmaceutical, administrative, and/or coordinator environment or bachelor’s degree (science discipline preferred) + 2-3 years of experience in a pharmaceutical, administrative, and/or coordinator environment.
- Strong Verbal and Written Communication skills.
- Excellent interpersonal skills.
- Understanding of Good Documentation Practices
- Strong organizational and prioritization skills.
- Ability to multi-task in a fast-paced environment
- Adept at attention to detail
- Strong understanding of Good Documentation Practices
- Familiarity with medical terminology.
- Work effectively and cooperatively with others; establish and maintain good working relationships.
- Computer literate-proficient in use of Microsoft Office. Must be able to understand and utilize complaint database software and reporting tools.
- Ability to multitask in a highly stressful environment