Complaints Manager

Location: Mexico City (Hybrid)

At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognized for your commitment and contributions and see your career like never before. Together we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse talented people to join Alcon.

As a Complaints Manager supporting the Quality Assurance team you will be responsible for leading and coordinating regional complaint handling pharmacovigilance and Techno vigilance activities across all LACAR countries ensuring compliance with Alcon Quality System requirements applicable local and international regulations and corporate procedure for all Alcon products.

This role acts as a regional subject matter expert (SME) for vigilance activities leading the complaints intake team and supporting affiliates in the proper execution of complaint and adverse event processes and ensures consistent timely and compliant intake investigation reporting and closure of complaints adverse events and field safety information for drugs and medical devices

In this role a typical day will include:

• Lead and oversee Pharmacovigilance and Techno vigilance activities for LACAR ensuring compliance with applicable regulations guidelines and Alcon global procedures.
• Ensure timely intake triage followup investigation documentation customers letters and closure of:
  • Quality and technical complaints
  • Adverse events and serious adverse events
  • Field safety information and market actions
  • Regulatory Submission
• Act as regional point of contact and SME for vigilance-related topics supporting local affiliates and escalating issues as required
• Ensure the effective execution of the complaint handling process in alignment with Alcon QMS and regulatory requirements (e.g. ISO 13485 applicable PV/TV regulations).
• Monitor and drive compliance with complaint KPIs timelines and quality metrics across LACAR.
• Support root cause analysis risk assessment trend analysis and CAPA related to complaints and vigilance activities.

• Ensure proper documentation and data integrity in corporate systems used for complaints and vigilance reporting.

• Responsible for coordinating the operations and tasks completion within SLAs for QAC team including tracking the volumes of BAU workload distribution back-up system and metrics indicators.
• Support and coordinate regulatory reporting obligations related to pharmacovigilance (aligned with the External Vendor Profarma) and Techno vigilance activities in collaboration with local affiliates and Global teams.
• Act as a regional support during health authority inquiries inspections audits and investigations related to complaints and vigilance processes.
• Provide functional guidance and support to local QA / RA teams across LACAR to ensure consistent application of vigilance processes as well as to the QAC team members
• Collaborate closely with Global Quality Safety Regulatory Affairs Commercial Supply Chain and external vendors and act as single point of contact for the QAC activities to ensure effective communication and issues management & Inform management of potential safety issues emerging trends and/or concerns
• Contribute to regional and global initiatives related to vigilance process optimization digitalization and continuous improvement.
• Support the development and deployment of training programs related to complaint handling pharmacovigilance and Technovigilance for LACAR teams as well as on-boarding and training of new team members.
• Identify opportunities to simplify harmonize and improve regional vigilance processes while maintaining compliance.
• Advise the business local affiliates and regional teams on New Regulations Impact on Alcon policies procedures and quality system requirements ensuring their appropriate interpretation and application.
• Plays integral part of the investigation team for high risk or sensitive complaint quality investigations and assists the team to manage these cases effectively.
• Maintain a working knowledge of company policies and procedures departmental processes and associated work instructions to ensure an understanding of information/data collection required and associated timelines for technical and AE complaints to assure compliance with regulations and directives.
• Directly manage and develop regional QA Complaints / Vigilance teams located in Brazil and AGS Mexico ensuring adequate resource allocation role clarity and workload balance. Provide leadership coaching performance management and development feedback to direct reports aligned with Alcon values and leadership expectations.

WHAT YOULL BRING TO ALCON:

• Education: Bachelors degree in a scientific pharmacy or healthcare-related discipline. Masters degree or equivalent desirable
• 5 years of experience in Quality Assurance Pharmacovigilance Technovigilance or Complaint Handling within medical device and/or pharmaceutical industry

• Solid knowledge of pharmacovigilance and technovigilance regulations complaint handling processes and Quality Management Systems (e.g. ISO 13485).
• Experience working in regional or multi-country environments
• Leading team on assigned projects
• Fluency in English and Spanish (Portuguese is a plus) both spoken and written is a requirement
• Strong analytical organizational and communication skills.
• Computer literacy with standard software platforms
• Ability to manage priorities work independently and collaborate effectively with crossfunctional and multicultural teams.
• Demonstrated people management experience including leading teams in regional or multisite environments

HOW YOU CAN THRIVE AT ALCON:

• Opportunity to join a growing early-stage organization built within a mature stable global company.
• Friendly working environment and a diverse and highly motivated team
• Individual career development plan and possible career growth within a newly created account
• Truly international environment and daily interactions with colleagues and stakeholders from all over the world
• Attractive benefits & compensation package
• Flexible hours and remote work possibilities (min 3 days per week office-based)

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Alcon is an Equal Opportunity Employer and 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 gender identity marital or veteran status disability or any other legally protected status.