Novartis Pharmaceuticals Medical Safety Specialist in Fort Worth, Texas
Job ID 197183BR
Posting Title Medical Safety Specialist
Division Global Drug Development
Business Unit CMO & PATIENT SAFETY GDD
Work Location Fort Worth, TX
Company/Legal Entity Alcon Research, Ltd.
Functional Area Research & Development
Therapeutic/Disease Area Ophthalmics/Ophthalmology
Job Type Full Time
Employment Type Regular
Job Description •Responsible for day-to-day case management of technical and adverse event complaint records involving Alcon manufactured products.
•Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives.
•Manages technical and adverse event complaint records for assigned therapeutic area(s) using designated safety system(s)
•Reviews potential complaint data received via safety system(s) and other methods, as required
•Performs intake/data entry activities and attaches corresponding source documents for affiliates without access to safety database(s).
•Completes required seriousness/reporting assessment(s)
•Assigns codes required to characterize reported event(s) and support signal detection, risk management activities, and trend analysis
•Reviews new information to determine potential influence on seriousness/reporting assessments (i.e. correspondence, completed questionnaires, medical records, service requests, investigation findings…..)
•Prepares and submits expedited and periodic regulatory reports, when required
•Reviews data entry and follow-up activities for completeness and timeliness
•Closes files according to established guidelines to meet required timelines
•Provides support for: internal and external audit activities, preparation of aggregate reports, responding to follow up questions from regulatory agencies
•Maintains a working knowledge of: company policies and procedures, departmental processes, and associated work instructions, evolving local and international regulations, guidelines and applicable directives, Alcon products for assigned therapeutic area(s) and corresponding documentation (Product Inserts, DFUs, Manuals, Promotional Materials), eye anatomy, common diseases, ophthalmic evaluation procedures, eye terminology and abbreviations, safety databases(s) and reporting tools
•Informs management of potential safety issues, emerging trends and/or concerns
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or 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. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to firstname.lastname@example.org and let us know the nature of your request and your contact information
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.
•Bachelor’s Degree (healthcare or science discipline preferred) or applicable healthcare education / certifications (i.e. RN, LVN, COMT, COT, COA, CCOA), or a combination of preferred skills, and experience.
•1-3 years relevant work experience (i.e. device/drug safety, compliance, quality assurance, regulatory affairs)
•3-5 years clinical experience – ophthalmology preferred
•Excellent time management and prioritization skills
•Ability to work effectively within strict timelines
•Task and detail-oriented
•Ability to work in a global cultural environment
•Computer proficiency (data entry, retrieval and analysis)
•Excellent written and verbal communication skills
•Sensitive to confidentiality of data