Tech Stack

Description

In this role, you will oversee adverse experience processes related to product complaint handling, ensuring consumer health and adverse events are managed per protocols. You'll conduct clinical evaluations for litigation cases and collaborate cross-functionally to ensure regulatory compliance and timely submissions.

Requirements

• 2-5 years experience in medical device, pharmaceutical or tobacco post-market surveillance
• Experience with adverse event reporting to FDA/Health Authorities
• Bachelor's degree in nursing or applicable RN license
• Intermediate to advanced MS Excel skills (Pivot tables, VLOOKUP, formulas)
• Strong analytical and organizational skills

Responsibilities

• Oversee adverse experience processes for product complaint handling
• Conduct comprehensive clinical evaluations for litigation cases
• Ensure timely SAE/UAE submissions to FDA
• Perform daily and weekly surveillance reporting
• Support internal and external audits