Safety Reporting Specialist
Core
Manage and coordinate the production of regulatory and safety reports, ensure accurate documentation of adverse events, and support compliance with global pharmacovigilance requirements.
Role type
Safety Reporting Specialist
Builds
Regulatory and safety reports for global pharmacovigilance compliance
Domain
Life Sciences / Pharmacovigilance
Required skills
Medical terminology, Safety database functionality, FDA regulations knowledge, Attention to detail, Critical thinking, Problem-solving
Preferred skills
Project leadership, Training delivery, Process improvement
Technologies
Microsoft Word, Microsoft Excel, Safety databases
Responsibilities
Receive, prepare and submit safety reports to applicable parties; Assist in producing metrics and alerts; Participate in project teams; Provide training and support for team members; Perform administrative tasks such as filing and system maintenance; Liaise with various departments; Participate in audits and testing activities.
Seniority
Mid-level, hands-on IC
