Reporting Specialist II
Core
Execute all reporting and vigilance submissions for pharmaceutical and medical device complaints, ensuring compliance with global regulatory requirements.
Role type
Senior IC reporting specialist (pharmacovigilance)
Builds
Local and global vigilance reporting submissions
Domain
Life sciences / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory requirements knowledge, FDA Quality Systems knowledge, Medical Device Reporting regulations knowledge, complaint management, translation services, process improvement, mentorship
Preferred skills
Life sciences/pharmacy/nursing background, cGMP industry experience, clinical setting experience, prioritization of multiple projects
Technologies
Word processing systems, complaint management systems
Responsibilities
Lead all vigilance reporting including local and global submissions, partner with pharmacovigilance and regulatory affairs teams, ensure stakeholder visibility into reporting processes, manage complex reporting needs and external requests, own translation services for reporting, provide mentorship to junior team members
Seniority
Senior, hands-on IC