Sr Safety Reporting Specialist
Core
Lead and oversee the preparation of complex safety reports, ensure compliance with international pharmacovigilance regulations, and drive continuous improvement in reporting processes to safeguard patient health.
Role type
Senior Safety Reporting Specialist (Pharmacovigilance)
Builds
Regulatory-compliant safety reports and improved departmental procedural documents
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical terminology, Global safety reporting requirements, Microsoft Office, Database functionality, Critical thinking, Problem-solving, Time management, Multi-tasking, Attention to detail, Influence and negotiation
Preferred skills
Mentoring, Financial project involvement, Process development
Technologies
Microsoft Office, Database systems
Responsibilities
Receive, prepare, and submit safety reports to applicable parties; Lead large-scale projects to ensure timely report submission; Provide input and feedback for procedural document development; Liaise with relevant departments on safety reporting tasks; Produce metrics and assist in financial projects; Mentor new starters and provide guidance to team members.
Seniority
Senior, hands-on IC with mentorship responsibilities
