Patient Safety and Pharmacovigilance Specialist
Core
Coordinate international adverse event reporting and pharmacovigilance activities to ensure regulatory compliance and patient safety across global clinical trials.
Role type
Senior IC pharmacovigilance specialist
Builds
Safety reports, performance metrics, and audit-ready compliance documentation for drug development
Domain
Life sciences / Clinical research / Regulatory compliance
Required skills
Adverse event assessment, regulatory submissions, root cause analysis, audit support, training delivery, Argus Safety database management, literature review, cross-functional collaboration
Preferred skills
BPharm, PharmD, RN, MD, MSc, experience in CRO or pharma, Phase I–IV clinical trial support
Technologies
Argus Safety, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Monitor pharmacovigilance system and prepare monthly performance reports; Compile and trend compliance data, perform root cause assessments, and evaluate corrective actions; Review safety reports and clinical study documentation for accuracy; Support audit and inspection readiness; Provide training on adverse event reporting; Manage safety mailbox and coordinate medical evaluations; Develop Safety Monitoring Plans and process adverse events in Argus; Review and submit safety reports to regulatory agencies; Conduct literature reviews to identify potential adverse events; Act as pharmacovigilance subject matter expert and support team onboarding
Seniority
Mid-to-Senior, hands-on IC with subject matter expertise
