FSP Safety Reporting Specialist (Night Shift)
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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical terminology, Safety database functionality, FDA regulations and guidelines knowledge, Microsoft Word and Excel, Attention to detail, Critical thinking, Problem-solving
Preferred skills
Project leadership, Process improvement initiatives, Training and support for team members
Technologies
Safety databases, Microsoft Word, Microsoft Excel
Responsibilities
Receive, prepare and submit safety reports to applicable parties; Assist in producing metrics and alerts regarding quality or timeline issues; Participate in project teams and lead small to moderate scope projects; Perform administrative tasks such as filing and maintenance of safety reporting systems; Liaise with various departments regarding safety reporting tasks and client account setup; Participate in audits and perform testing activities as needed.
Seniority
Mid-level, hands-on IC
