Expert Specialist-Product Complaint Quality

Eli Lilly and Company; Petaling Jaya; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading healthcare company seeks a Responsible Complaint Person to oversee product complaint activities in Asia-Pacific. The role involves collaboration with various teams, data management, and compliance monitoring to ensure timely resolution of complaints.

Qualifications

• Experience in complaint management and data handling.
• Ability to translate Mandarin to English.

Responsibilities

• Oversee all Product Complaint activities in Asia-Pacific.
• Collaborate with business partners for case reporting.
• Monitor and ensure timely closure of complaints.

Skills

Complaint Management

Data Analysis

Translation

Communication

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We dedicate ourselves to our work and prioritize people. We seek individuals determined to improve lives globally.

This role oversees all Product Complaint activities related to Lilly products marketed in China and the Asia-Pacific regions (ASEAN). The position involves collaborating with various business partners to ensure timely case reporting and resolution, as well as managing APRC China Satellite Regional Center activities. The role is based in Kuala Lumpur, Malaysia.

China Affiliate RCP (Responsible Complaint Person) – Product Complaint

• Complaint Initiation, Follow-up, and Closure
• Collect complaint data from sources such as Lilly China Answer Center, business partners, and Lilly employees across China and ASEAN regions.
• Classify reports as Product Complaint (PC), Adverse Event (AE), combined PC & AE, or inquiry based on Lilly criteria.
• Translate written PC and/or associated AE information from Mandarin to English accurately.
• Enter translated information into the electronic database.
• Confirm receipt of reports from third-party organizations.
• Follow up with Chinese reporters for additional data and sample retrieval.
• Coordinate with Patient Safety, APRC, and cross-functional teams to handle complaint-related issues.
• Monitor case overdue status to ensure timely closure per Lilly standards.
• Respond to reporters verbally or in writing as appropriate.
• Support suspect reporting of Lilly products.
• Identify and escalate urgent reports to quality leadership.

Complaint Monitoring, Trending, and SOP Maintenance

• Reconcile AE/PC events periodically with internal/external partners to ensure complete and timely reporting.
• Develop and update training and documentation related to PC.
• Consolidate and analyze PC metrics to monitor trends and identify potential safety issues.

APRC China Satellite Assessment and Analysis

• Assess complaint information, assign appropriate levels and categories.
• Determine need for further investigation and escalate to quality units.
• Gather supplementary information as needed.
• Review complaint records for completeness and compliance.
• Establish effective relationships with manufacturing and packaging sites to facilitate investigations.
• Work within teams to meet deadlines and improve processes.
• Ensure compliance with local regulations.

Lilly is committed to ensuring equal employment opportunities for individuals with disabilities. If accommodations are needed during the application process, please complete the workplace accommodation request form. Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or other protected categories.

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