Perform device safety activities for assigned Novartis/Alcon projects or products, including identification and comprehensive assessment of safety signals from all sources (clinical through post-approval lifecycle management and externally). May function as a BSL for products in which no BSL is assigned.
1.Perform single case medical review in the safety database or line listings. Medical review will be performed by clinically/medically qualified associates. 2.Monitor the clinical safety of assigned products/projects, including literature review, adverse events, patient impact from technical complaints and signal detection. 3.Provide safety input into clinical and regulatory deliverables, including Investigator s Brochures, study protocols, reports, and clinical submission documents, as needed. 4.Identify safety signals based on the review of solicited or unsolicited singles cases. Perform signal triage activities, evaluation, and presentation to Novartis/Alcon Boards including preparatory activities. 5.Author or provide safety input to the product labeling and related documents. 6.Author the safety profiling and risk management documents. 7.Provide guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports. 8.Lead cross-functional projects; provide guidance and collaborate productively with colleagues from CMO & Patient Safety and business franchise functions. 9.Provide expert medical/scientific input into responses to inquiries from health authorities, healthcare professionals, local affiliates, or legal on safety issues. Prepare safety data for health authority review boards. 10.Support licensing activities, health authority inspections/audits, and project/product recall activities, as needed. 11.Mentor and coach junior associates within the Safety Management Team or cross-functionally. 12.May function as a deputy for BSL for complex assignments, including SMT chair.
Timeliness and quality of safety analyses, interpretations and presentations Compliance with internal and external regulations and procedures
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.
Master of Science or health-related discipline is required. MD or OD is preferred but essential for associates performing medical review of single case reports. Fluent in the English Language. At least 4 years of industry experience in product development, including 2 years in safety at an operational or medical position. Clinical expertise in ocular anatomy and ophthalmic procedures. Technical expertise in ophthalmic medical devices. Proven ability to analyze, interpret, and discuss safety information. Excellent written and verbal communication skills. Experience in product development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications. Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information. Demonstrates strategic thinking and problem solving skills. Experience with (safety or others) issue management. Ability to work under pressure, demonstrating initiative and flexibility. At least 3 years of clinical experience post-doctoral preferred
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