Associate, Global Complaint Management

24 hours ago

tamil nadu, India ICU Medical Full time

DescriptionRole: Analyst, Global Complaint Management (Customer Response)Team: QualityDesignation: AssociateLocation: Chennai, IndiaPosition 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 Draft and send professional, clear responses to customer complaints regarding medical devices, gather additional information for events as needed, ensuring compliance with regulatory standards and timelines.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 Writing skills are essential for drafting clear responses to customer complaints, creating customer letters, and writing complaint narratives.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.Able to create Customer Letters.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 as applicable. 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 QualificationsMust be at least 18 years of age.Must pass pre-employment background check.Physical Requirements and Work EnvironmentThis is largely a sedentary role.This job operates in a professional office environment and routinely uses standard office equipment.

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