Sr Safety Specialist
Core
Senior Safety Specialist performing Pharmacovigilance (PV) activities to ensure patient safety and operational excellence in a highly regulated pharmaceutical environment.
Role type
Senior IC Pharmacovigilance Specialist
Builds
Safety information processing, regulatory compliance, and clinical trial support for top 50 pharmaceutical companies and 750+ biotechs
Domain
Life Sciences / Pharmacovigilance / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance case management, regulatory compliance knowledge, therapeutic area expertise, clinical study administration, budget forecasting, audit preparation, mentorship, critical thinking, data quality review
Preferred skills
None stated
Technologies
Microsoft Office (Outlook, Word, Excel), multiple clinical databases
Responsibilities
Collect, monitor, assess, evaluate, research, and track safety information; review cases for quality, consistency, and accuracy; collaborate with project teams, clients, investigators, and vendors; participate in on-call duties for 24-hr case intake; develop procedural documents; maintain knowledge of global regulatory requirements; coordinate routine project implementation including Clinical Trials and Data Safety Monitoring Committees; present at client/investigator meetings; review metrics and budget considerations
Seniority
Senior, hands-on IC with lead capacity and mentorship responsibilities
