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 documentation for pharmaceutical/medical device clients
Domain
Life Sciences / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Medical terminology, Global safety reporting requirements, Procedural document development, Project leadership, Metrics production, Financial project involvement
Preferred skills
Database functionality, Mentoring new starters, Cross-departmental liaison, Financial project involvement
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; Liaise with relevant departments around safety reporting tasks; Provide input, feedback and guidance to other team members and mentor new starters; Produce metrics and have some involvement in financial project.
