JOB PROFILE General Job Title Associate I Job Grade JL-7 Medical Safety 7 01 Department Product Quality Surveillance Customer Affairs Reports to Name Job Title Manager I Global Device Vigilance Job Purpose State in one sentence the overall objective of the job The role provides day-to-day case monitoring assessment and reporting of quality and adverse event complaint records involving Alcon manufactured products and responds to complaint activities required to comply with local and international regulations guidelines and applicable directives This role may be required to work in shifts Major Accountabilities Describe the main results of the job to be achieved Case Processing Process case files according to Standard Operating Procedures SOP Work with affiliate offices to ensure required dataset has been received requested Re-assess the data ensure accurate product selection and assign required event code s in the system Complete initial and follow-up reporting assessments as information is received initial report follow-up questionnaires phone calls investigation findings Respond to Manufacturing Quality Assurance QA requests and Health Authority inquiries Launch required quality investigation records Schedule expedited and periodic regulatory reports based on local and international reporting regulations Perform and receive quality feedback on case management and coding Adherence to all corporate compliance guidelines corporate programs Maintains a working knowledge of the following Alcon Products for assigned therapeutic areas and corresponding documentation Product Information Directions for Use Manuals Promotional materials Eye anatomy Common diseases Ophthalmic evaluation procedures Eye terminology and abbreviations Safety database s and reporting tools Process and review Surgical - Intra Ocular Lens IOL complaint records in accordance with Alcon Standard Operating Procedures SOPs Provide support in reconciliation activities and audit as required Evaluate and escalate potential safety issues to management Role Dimensions Number of associates None Financial responsibility None Impact on the organization Low Key Performance Indicators Indicate how performance will be measured indicators activities KPIs will be outlined in detail in the goal sheet and will largely be around below parameters Meets internal and external quality standards Review and close files within prescribed timelines Creates high quality regulatory reports for submission on or before assigned due dates Ideal Background State the minimum and desirable education and experience level Education Minimum Graduation in Science Desirable Graduation in Optometry Pharmacy M Pharm B Pharm BDS BAMS BHMS Biomedical Engineering Registered Nurse Experience requirement Minimum Healthcare professional with 1-2 years of experience Desirable Experience in Device Vigilance Pharmacovigilance Regulatory Submissions Clinical Research PVPI Medical Coding Languages Minimum English written and spoken Specific Qualified Competencies Indicate any other soft technical professional knowledge and skills requirements Excellent listening ability and communication skills Excellent decision quality and negotiation skills Ability to manage multiple tasks attention to detail prioritize work and manage time well Knowledge and understanding of national and international medical device regulations and regulatory guidelines Knowledge of medical aspects of medical device safety medical device vigilance in pre- and post-marketing safety practice Basic knowledge of MS Office Associate Name SAP ID Signature Date HR SPOC ATTENTION Current Alcon Employee Contingent Worker If you are currently an active employee contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site Find Jobs for Employees Find Jobs for Contingent Worker Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital status disability or any other reason