This position performs triage, data entry and follow-up on product complaints received by Purdue. This position monitors the quality of data entered in to the Product Monitoring databases and reconciles the data entered. In reconciling data, this position acts as a resource for answers to operational questions related to case processing and department procedures. The primary responsibilities of this position are to triage, data enter, follow-up and perform quality checks and audits on product complaints received by Purdue. To accomplish these objectives the person filling this position will have the necessary experience and operational skills to evaluate records received by Product Monitoring, process records per department procedures, and conduct audits and quality reviews. PRINCIPAL ACCOUNTABILITIES: All Product Monitoring Associate accountabilities as time allows, plus 1. Triage information received by Product Monitoring in accordance with SOPs to determine if criteria are met to process the information as a product complaint (PC), and to determine if the information received is to be forwarded to another group/department (i.e., adverse event information, product suggestion, security issue, etc.) for action/awareness 2. Conduct and resolve daily, weekly, monthly, and periodic audits of Product Monitoring data as well as quality checks of data entered into the PC database; the source document database, and other department metrics as required. 3. Resource for answers to operational questions related to case processing and department procedures when asked during reconciliation of an audit 4. Reconcile data exchanged between Product Monitoring and third party agreement holders (i.e., when reconciliation is specified in Quality Agreements and or Pharmacovigilance Agreements). 5. Document corrective actions and maintain appropriate files 6. Assist in providing documents from within the Product Monitoring Group (i.e. audit requests, listings for product reviews, etc.) 7. Assist in development of metrics and budgets 8. Perform non IT related PC database maintenance 9. Participate in projects, interdepartmental meetings and departmental tasks assigned by the Director Product Monitoring or designee (i.e., internal/external audits; revise assigned SOPs, present at assigned meetings, conduct specific training, etc.) 10. Assist in other departmental tasks, as assigned by the Director Product Monitoring to assure Purdue's compliance with all FDA and ICH regulations and guidelines governing the reporting of PCs
Bachelors degree in science or healthcare related field or equivalent combination of education and experience.
Required Experience & Technical Requirements
Technical Requirements • Minimum 5 years of Pharmaceutical, Healthcare, or similar FDA regulated industry experience required
Minimum of 4 years of PC pharmaceutical industry or other similar FDA regulated healthcare environment required (i.e., receipt/monitoring PC cases, conducting/monitoring quality complaint investigations, etc.) • This position requires basic knowledge of GCP, GMP and advanced understanding FDA regulations governing the capture, tracking, and reporting of pharmaceutical PCs. • Job requires excellent verbal/written communication skills and ability to respond effectively and in a timely manner to a high volume of PCs, as well as the ability to work under pressure within a high paced environment. • Requires working project management skills and the ability to effectively prioritize and manage individual and others workload • Proficiency in electronic PC database management and electronic case processing • Audit or quality experience required with ability to conduct QC review of PC case files • Working knowledge of PC coding • Working knowledge of PC and drug safety related processes • Understanding of regulatory and organizational requirements with advanced knowledge of eDOC or similar document management system • Ability to influence others and an understanding of training concepts Preferred Skills: • Working knowledge of SAP & Trackwise • Knowledge of budget and metric processingBrief Description/Overview:
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P. - 18 months ago