Complaint Vigilance Specialist I
Core
Execute vigilance activities for pharmaceutical and medical device complaints, ensuring accurate reporting to regulators and internal stakeholders.
Role type
Senior IC compliance specialist (pharmacovigilance)
Builds
Regulatory submissions and compliance reports for pharmaceutical and medical device products
Domain
Life sciences / Regulatory compliance
Deliverable
client delivery
Required skills
Reportability decision making, global regulatory requirements knowledge, FDA regulations knowledge (21 CFR 803, 820, 211), complaint management systems proficiency, cross-functional collaboration
Preferred skills
Life sciences/pharmacy/nursing background, cGMP industry experience, clinical setting experience, prioritization of multiple projects
Technologies
Computer systems for word processing and complaint management
Responsibilities
Lead all vigilance reporting including local and global submissions, interface with regulators, manage end-to-end reporting timelines, own translation services for reporting, ensure stakeholder visibility into reporting processes
Seniority
Mid-level, hands-on IC