Senior/Principal Drug Safety Specialist (Night Shift)
Core
Senior/Principal Drug Safety Specialist performing Pharmacovigilance (PV) activities to ensure patient safety and operational excellence in a highly regulated pharmaceutical environment.
Role type
Senior/Principal IC Drug Safety Specialist (Pharmacovigilance)
Builds
Safety data management, regulatory compliance, and clinical trial support for top 50 pharmaceutical companies and 750+ biotechs
Domain
Life Sciences / Pharmacovigilance / Clinical Trials
Required skills
Pharmacovigilance case management, regulatory compliance, therapeutic area knowledge, critical thinking, clinical study administration, budget forecasting, audit preparation, mentorship, global regulatory requirements understanding, data analysis
Preferred skills
None explicitly stated
Technologies
Microsoft Office (Outlook, Word, Excel), multiple safety 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; attend audits; present at client/investigator meetings; manage project implementation and coordination including Clinical Trials and Data Safety Monitoring Committees
Seniority
Senior/Principal, hands-on IC with mentorship responsibilities (via careerplan.io/jobs/R-01370226-seniorprincipal-drug-safety-specialist-night-shift-at-thermofisher)