Associate, Global Complaint Management

Job Description

Role: Analyst, Global Complaints Management

Team: Quality

Designation: Associate

Location: Chennai, India

Position Summary

The position is responsible for managing device or pharmaceutical complaints and adverse events globally. Duties may include the following: initial triage of complaint files, assessments of reportability, escalating customer advocacy events, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable department, obtaining additional information for events, providing updates to reports, and assuring timely processing of complaint files with regards to regulatory reporting.

Essential Duties & Responsibilities

• Serve as the primary customer contact to collect event registration information from customers per SOPs.
• Manage complaint lifecycle: registration, sample retrieval, investigation, and closure/reopening.
• Gather additional information for events as needed.
• Handle customer advocacy issues and escalate complex events with significant consequences to Specialist/Team Lead.
• Provide accurate information to customers (verbal/written) during the process.
• Oversee event management, including customer response and closure/reopening.
• Coordinate with SMEs, GCM Specialist/Team Lead for event resolution.
• Stay updated and compliant with company policies, including Information Security Management Systems.
• Maintain confidentiality and security of all company and customer information.
  
  

Knowledge, Skills & Qualifications

• Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.
• Requires the ability to speak effectively to bio-medical engineers and/or health care providers in order to gather the necessary detailed data from customers.
• Able to think critically to determine the type of questions which need to be asked to gather necessary information and demonstrate ability to collect, analyze and interpret complaint and adverse event information.
• Able to write narratives regarding the complaints.
• Must have good computer skills, effective keyboarding skills.
• Must have excellent telephonic and listening skills.
  
  

Education And Experience

• Required: Graduate of Science or Medical Engineering or Graduate of Allied Science.
• Preferred: Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology/ Clinical Laboratory Science and experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business.
• Individual should have work experience of 3-7 years in a similar role: experience in a medical device organization is a plus.
  
  

Minimum Qualifications

• Must be at least 18 years of age.
• Must pass pre-employment background check.
  
  

Physical Requirements And Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.