Associate II, Complaints

Alcon; Selangor; On-site; MYR 45,000 - 60,000; Full time

Job summary

A global medical device leader in Malaysia is seeking a Case Manager to oversee the handling of quality and adverse event complaints. The ideal candidate will have a tertiary qualification in healthcare and 1-2 years of experience in the pharmaceutical or medical device industries. Responsibilities include managing complaint records, ensuring regulatory compliance, and contributing to quality assurance efforts. This role offers competitive compensation and opportunities for professional growth.

Benefits

Competitive compensation package

Comprehensive benefits

Continuous learning and development opportunities

Qualifications

• 1-2 years of experience in pharmaceutical and medical device industries.
• Proven ability in implementing quality and documentation systems.

Responsibilities

• Manage day-to-day case management of complaint records.
• Ensure compliance with local and international regulations.
• Handle intake, follow-up, and triage for quality complaints.

Skills

Technical Competence

Customer Focus

Effective Communication

Education

Tertiary qualification in healthcare discipline

Job description

Overview

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, you’ll 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.

POSITION OVERVIEW

Responsible for day-to-day case management of quality technical and adverse event complaint records, including intake, follow up, triage, system entry- and final response, involving Alcon devices, pharmaceutical products and OTC products. Complaints handling accountabilities reflect activities required to comply with local and international regulations, guidelines and applicable directives.

Key Responsibilities

• Ensure compliance of the regional/country complaint handling process for all Alcon products, including intake, follow up and triage for reports of quality/technical complaints and Adverse Events in compliance with local and international regulations, guidelines and applicable directives.
• Receive initial complaint from any source (ECPs, patients, internal Alcon personnel) and assure all information/data is accurately captured at point of contact
• Maintain an understanding of information or data required to be collected of technical and AE complaints to assure compliance with regulations and directives
• Manage technical and adverse event complaint records for assigned areas using designated safety systems
• Review potential complaint data received via safety systems and other methods as required
• Perform intake/follow up/data entry activities and attached corresponding source documents in a timely manner per requirements and directives
• Perform all necessary reconciliation activities including for all customer-oriented programs in accordance with procedures
• Triage/address calls from all sources for quality technical complaints, Adverse Events, and assist into the request for refund, request for replacement product and requests for credit
• Adheres to required metrics for all complaint intake responsibilities
• Arrange for replacement, product return and shipping of samples to QA side for analysis
• Closes files according to established guidelines to meet required timelines
• Maintain a working knowledge of company policies and procedures, departmental processes, and associated work instructions
• Monitor the evolving local and international regulations, guidelines, and applicable directives, and inform regional/global of the changes in a timely manner
• Alcon products for assigned therapeutic areas and corresponding documentation (Product Insets, DFUs, Manuals, Promotional Materials)
• Support, collaborate and ensure country inspection readiness (internal and/or external). Support for and close out of audits, corrective plan, investigation, related to vigilance. Proactively identify compliance issues and compliance gaps, follow up and closure of observations in close cooperation with regional and global
• Responsible country(ies): APAC and GEM

Key Performance Indicators (KPI)

• Quality and timely reporting of KPI and customer response
• Complaint and/or AE intake reporting compliance
• No critical findings in audits or inspections
• Customer feedback and satisfaction

Associate is authorized

• To manage any follow up with the complainant, and to update into the GPCMS
• To prepare the final response according to the Quality Summary (prepared by Alcon's global device vigilance colleague) and forward the notification to the Healthcare Professional
• To arrange the return of any product compliant sample to the manufacturer for investigation
• To manage and work within Alcon representative into any customer and/or product responses, and feedback within agreeable timeline
• To conduct reconciliation with Alcon representative and report out within agreeable timeline

What you’ll bring to Alcon

• Tertiary qualification in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline

Languages

• Fluent in English.
• Additional language proficiency will be an advantage.

Key Competencies / Behaviours

• Technically Competent
• Results Driven
• Customer / Quality Focus
• Empowerment / Accountability
• Mutual Respect / Trust / Loyalty

Experience

• 1- 2 years of experience in pharmaceutical and medical device industries
• Proven ability in implementing quality and documentation systems
• Record of accomplishment of tracking complaints
• Effective communicator

How you can thrive at Alcon

• Opportunity to work with a leading global medical device company
• Collaborate with a diverse and talented team in a supportive work environment
• Competitive compensation package and comprehensive benefits
• Continuous learning and development opportunities

Alcon Careers

See your impact at alcon.com/careers

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