Senior Pharmacovigilance Scientist (Vaccines/ Products of National Significance)
Core
Lead safety review, signal detection, and risk management for CSL vaccines and products of national significance across their lifecycle.
Role type
Senior Pharmacovigilance Scientist (Vaccines/Products of National Significance)
Builds
Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans, and aggregate safety reports.
Domain
Pharmaceutical industry, Vaccines, Pharmacovigilance, Global Clinical Safety
Required skills
Pharmacovigilance lifecycle management, Signal detection and analysis, Regulatory reporting (PSUR/DSUR/RMP), Clinical data review, Cross-functional collaboration, Scientific literature review, Case adjudication, Strategic benefit-risk evaluation
Preferred skills
Safety monitoring, Signal detection, ICH GCP knowledge, Drug development lifecycle knowledge
Technologies
Microsoft Excel, Database entry tools
Responsibilities
Lead safety review process and evaluation of safety data using quantitative and qualitative approaches; Perform end-to-end signal detection and analysis on safety data sets; Review scientific and medical literature for safety information; Provide strategic input to aggregate safety reports; Organize insights for Safety Management Teams; Support product development teams with PV expertise; Develop response strategies for regulatory requests; Mentor junior PV scientists.
Seniority
Senior, hands-on IC with mentorship responsibilities