* Manage collection, processing, documentation, reporting and follow-up of all product complaints and adverse event reports (AEs) for all Alcon products from clinical trials, non-interventional studies, Customer Oriented Marketing Programs, literature, spontaneous reports, social media, etc. Transcribe, translate and entry of all data from source documents into global product complaint management system and/or safety database in the required quality, format in a timely manner
* Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information
* Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources
* Work with other local/global Country Vigilance associates to ensure accurate evaluation of safety data
* Perform local literature screening for Alcon products marketed in accordance with Alcon procedures and local health authority requirement, if applicable
* Communicate with relevant parties (Medical Information, Medical Affairs, and Regulatory Affair) on the customer enquiry
* If defined by local regulations act as the Device Vigilance Responsible Person and as the single point of contact
* Being aware of local medical device and pharmacovigilance legislation/ guidance in the country (ies) of responsibility
* Inform global/ regional of any changes of the local device and safety legislation in a timely manner
* Survey monitor and document national device vigilance regulations and safety regulations, ensure that any changes are appropriately and immediately escalated to relevant stakeholders at regional and global
* Working with regional and global to ensure all required Vigilance Clause/ Safety Data Exchange Agreement/ Pharmacovigilance Agreement are in place, appropriate and up-to-date
* Ensure Alcon associates/ representative, 3rd party business partner, external vendors are adequately trained in product complaint and/or adverse event reporting
* Track, document and archive of vigilance training activities in line with local legislation and Alcon standards
* Develop and update training materials for device vigilance and ensure training of Alcon associates, representative on relevant vigilance/safety procedures for AE/complaint reporting, including field-based associates and third party contractors, if applicable
* Ensure the country is inspection ready for both internal audits and inspection from health authorities
* Develop, update and implement local procedures to ensure compliance with Country Vigilance procedures and local requirements
* Ensure that a business continuity plan is in place which is aimed at guarantee the uninterrupted availability of key vigilance processes and activities, or mitigate the impact of an unwanted event by means of measures and procedures enabling efficient and effective business resumption and/ or recovery, exists and has been tested accordingly
* Ensure support for and close out of audits, corrective action plan, investigation and health authority inspections related to vigilance
* Proactive identify compliance issues and compliance gaps, follow up and closure of observations in close cooperation with regional and global
* Ensure all vigilance procedures, organizational charts, curriculum vitae, training records documentation are accurate, current, and appropriately archived
* Monitor vendor’s working process to ensure safety reporting meet the country regulations.
* Support Regional Director in vendor performance review, reviewing the program proposal, SoW, and related documents
* In collaboration with the MPO, define acceptable wordings for the survey questions or response choices to minimize potential data entry risks, if applicable
* Handle customer enquiry on vision care products
