Complaint Vigilance Specialist I

📋 Description

• Decision maker for reportability decisions
• Lead for all vigilance reporting, including local and global submissions
• Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for
• Ensures that relevant stakeholders have visibility to the reporting and where they are in the
• Manages regular reporting needs and external requests (i.e. from the FDA)
• Manage the timeline for end to end reporting

🎯 Requirements

• Bachelor’s Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other
• 5+ years of work experience in a cGMP related industry or in a clinical setting (preferred)
• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination
• Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations
• Ability to prioritize multiple projects to ensure compliance with regulations and standard
• Solid written/verbal communication and organizational skills.

🎁 Benefits

• Enhanced Health and Wellness Coverage
• Extended Vacation
• Flexible Hybrid Work Model
• Life Insurance
• Employee Stock Purchase Plan