Sr. Specialist QA Technical Affairs
Responsible for day-to-day case management of unsolicited medical inquiries from eye care professionals, consumers and internal partners, including intake, follow-up, documentation, development and provision of responses involving Alcon device, OTC, and surgical pharmaceutical products. Triage requests appropriately and document interactions directly into the approved department medical information repository / database.
- Responds to unsolicited medical and technical product inquiries from external and internal customers and assigns highest priority to customer satisfaction. Responsible for day-to-day case management of inquiries, including intake, follow up, system entry, development and provision of responses involving Alcon device, OTC, and surgical pharmaceutical products.
- Maintains an understanding of information/data required to be collected for technical and medical inquiries to ensure compliance with regulations and procedures. Ensures customer satisfaction while meeting compliance requirements.
- Manages medical and technical inquiry records for assigned area(s) using designated medical information system (IRMS). Reviews data entry and follow-up activities for accuracy, completeness and timeliness. Closes files according to established guidelines to meet required timelines. Performs standard reporting from the Alcon inquiry management system and submits to management on a monthly basis.
- Performs intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per procedural requirements.
- Identifies potential product quality complaints and/or adverse events received via any source, and triages to medical/patient safety within required timeframe per Alcon policy. Completes adverse event/product complaint intake in the event complaint handling specialists are not available. Performs reconciliation of medical information cases with potential adverse events/product complaints.
- Conducts scientific literature searches of peer-reviewed journals and medical literature, develops standard response documents, and revises and updates existing documents in database.
- Maintains a working knowledge of processes, procedures, regulations, company systems, and reporting tools.
- Develops and maintains a working knowledge of Alcon products (labeling, usage, etc. for assigned therapeutic area(s) and disease states.
- Works independently while ensuring strategic alignment of information with key internal stakeholders and experts, as necessary. Collaborates with Commercial and Medical teams to provide medical information input on new product launches and product changes. Informs management of potential inquiry issues, emerging trends and/or concerns.
- Deliver Medical Information support at professional congresses per plan. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Bachelor's degree in Science, or equivalent years of education/experience required.
- Two years relevant work experience (i.e. device/drug safety, compliance, quality assurance, regulatory affairs).
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