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 procedural documents for patient safety
Domain
Life Sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical terminology, Global safety reporting requirements, Database functionality, Project leadership, Metrics production, Financial project involvement
Preferred skills
Mentoring new starters, Cross-departmental liaison, Critical thinking, Problem-solving, Negotiation
Technologies
Microsoft Office, In-house and off-the-shelf computer software
Responsibilities
Receive, prepare and submit safety reports to applicable parties; Lead large scale projects ensuring regulatory timeline compliance; Provide input and feedback to aid the development of program and departmental procedural documents; Produce metrics and have involvement in financial projects; Provide guidance to other team members and mentor new starters.
Seniority
Senior, hands-on IC with mentorship responsibilities
