ICU Medical Pharmacovigilance Analyst | Hybrid Pharma Jobs in Chennai | Apply Now
Explore exciting Pharmacovigilance jobs at ICU Medical in Chennai, India. This Analyst, GCM Vigilance Reporting role offers a hybrid working environment for professionals interested in Pharma Jobs Chennai, managing global device and pharmaceutical complaints while ensuring patient safety and regulatory compliance.
Job Details
- Job Title: Analyst, GCM Vigilance Reporting
- Job Identification: 434
- Location: Chennai, Tamil Nadu, India (Hybrid)
About the Company
ICU Medical is a global leader in pharma and medical device solutions, focusing on patient safety, regulatory compliance, and quality systems. The company provides innovative solutions in market surveillance, complaint management, and pharmacovigilance across FDA-regulated environments.
Job Description
The Analyst, GCM Vigilance Reporting position at ICU Medical is responsible for managing device or pharmaceutical complaints and adverse events globally. Responsibilities include triaging complaint files, assessing reportability, escalating customer advocacy events, submitting regulatory reports, referring safety cases to applicable departments, obtaining additional information, updating reports, and ensuring timely processing of complaint files according to regulatory requirements.
Key Responsibilities
- Evaluate complaints from a patient safety perspective and complete global regulatory reporting decisions
- Create and submit regulatory reports to the FDA and/or Regional Competent Authorities
- Obtain additional information for events as needed
- Escalate and assist with customer advocacy issues
- Manage complaint life-cycle including registration, sample retrieval, follow-up, investigation, and closure
- Provide accurate information to customers during verbal and written communication
Qualifications Required for Pharmacovigilance Jobs
Education and Experience
- Bachelor of Pharmacy and experience in a healthcare environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business.
Skills Required
- Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.
- Must be able to communicate effectively with internal and external customers.
- Demonstrate ability to collect, analyze and interpret complaint and adverse event information.
