Quality & Patient Safety Liaison Executive

Position Summary

The position is Product complaint event management and patient safety impact assessment.

Position Responsibilities

A.Regulatory Compliance and Documentation:

• Adherence to Good Documentation Practices (GDP) at all stages of document management, including creation, recording, storage, and maintenance.
• Ensure all critical complaint handling/assessment/reporting timeframe are fully adhered to.
• Categorize product complaints based on predefined criteria and/or decision trees, including clarifying with reporters to obtain complete event information for assessment.
• Perform initial assessment by analyzing each complaint with an understanding of medical knowledge and regulatory requirements across markets in which the products are sold, as per AE reporting requirement for local & cross-reporting, check occurrence rate, risk and severity level for serious cases.
• Communicate the adverse events to the line manager, regional regulatory affairs and any relevant stakeholders.
• Communicate significant manufacturing-related events to the appropriate departments.
• Support to translate foreign language complaint documents to English according to the competency, when necessary.
• Support relevant stakeholders whenever there are queries related to complaint, decision tree for the case, occurrence rate requests for selected failure mode in different period. Provide complaint and AE data whenever it is requested by internal stakeholders for dossier/license renewal/PSR/PSUR/trend report/FSCA/recall. Update and maintain the complaint database/ repository, tracker and folder with new complaints received and follow up with different stakeholders until the event is closed. Example: additional queries, material returning status, email coordination between Third Party Providers and reporter, and reporting to Competent Authority, investigation report from supplier and etc.
• Manage complaint related Return Goods Authorization.
• Prepare and present monthly complaint trending data to Quality and Manufacturing departments, and monthly complaint update to commercial team.
• Ensure that all documentation, both in electronic and hard copy formats, is accurate, complete, and properly dated to create an auditable trail that complies with regulatory standards.
• Act as a backup to the line manager.

B. Communication and Escalation:

• Liaise with inter-departments/company and external stakeholders on complaint material returning and investigation results/reports/letters.
• Assist in addressing critical information requests quality engineer to facilitate accurate assessment and thorough investigation of complaint.
• Escalate issues pertaining to challenges in obtaining necessary information, delays in communication, or other obstacles, to the line manager to ensure that timelines is maintain.
• Notify relevant parties and the line manager about non-conformances identified through complaints.

C. Training and Development:

• Develop training materials, such as presentations and videos, for the sales/marketing department on complaint handling process according to the region.
• Conduct training sessions for newly onboarded colleagues and distributors on complaint handling processes when necessary.

D. Portal Management and Miscellaneous:

• Create, maintain, and develop content on the SharePoint site for complaint handling, including a dedicated repository for complaint-related sources.
• Provide support when necessary to aggregate ad hoc reports related to complaint requested from different departments.
• Undertake any ad hoc assignments as required to support company operations.

Requirements

• Minimum 3 years experiences in patient safety or relevant job roles
• Bachelor in Nursing or Science, or the equivalent combination of relevant education and professional experience.
• Good knowledge of relevant EU guidelines US FDA (added advantage), initiatives and regulations governing post-marketing safety environments is desirable. Complaint handling experience a plus.
• Understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the medical device industry is highly desirable.
• Excellent oral and written communications with colleagues in Asian countries
• Proficiency in using Microsoft Office suite, including Excel.
• Ability to identify opportunities for continuous improvement.
• Excellent multi-tasking skills and ability to manage competing priorities and stringent timelines.
• Responsible for meticulously managing and safeguarding all information related to complaint handling.