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 methodology, Signal detection, Regulatory reporting, Benefit-risk evaluation, Case adjudication, Clinical data analysis, Scientific literature review, SOP development
Preferred skills
Safety monitoring, ICH GCP knowledge, Drug development lifecycle understanding
Technologies
Microsoft Excel
Responsibilities
Lead safety review process and evaluation of safety data; Perform end-to-end signal detection and analysis; Review scientific 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 staff.
Seniority
Senior, hands-on IC with mentorship responsibilities