Pharmacy Job at ICU Medical | Apply Now for the Analyst- Global Complaints Management Role
ICU Medical is hiring an Associate for Global Complaint Management to join its Quality team in Chennai, Tamil Nadu. This Pharmacy Job is ideal for Science, Medical Engineering, or Pharmacy graduates with 3–7 years of experience in a similar role. As a core member of the Global Complaints Management (GCM) team, the Associate will manage the lifecycle of medical device and pharmaceutical complaints, including initial triage, investigation, and the submission of regulatory reports. This Analyst Job requires strong critical thinking skills and the ability to interact effectively with healthcare providers in a professional clinical context.
- Job Role: Analyst, Global Complaints Management
- Location: Chennai, India
About The Company
ICU Medical is a global leader in the development, manufacture, and sale of innovative medical devices and pharmaceutical products used in infusion therapy, oncology, and critical care. Headquartered in the U.S. with a significant presence in Chennai, the company is dedicated to improving patient safety and clinical outcomes. ICU Medical operates within a strictly FDA-regulated environment, maintaining a world-class Quality and Global Complaints Management team to ensure the highest standards of vigilance and regulatory compliance.
Pharmacy Job 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 the applicable department, obtaining additional information for events, providing updates to reports, and assuring timely processing of complaint files with regard 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 the 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 biomedical engineers and/or health care providers to gather the necessary detailed data from customers.
- Able to think critically to determine the type of questions that need to be asked to gather necessary information and demonstrate the 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 for the Pharmacy Job
- Preferred: Bachelor of Science Degree in Pharmacy, and experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA-regulated business.
- An individual should have work experience of 3-7 years in a similar role: experience in a medical device organization is a plus for this Analyst Job.
