Senior Pharmacovigilance Scientist (Vaccines/ Products of National Significance)
Core
Monitoring, evaluating, and managing the safety profile of CSL medicines (vaccines/products of national significance) across their entire lifecycle.
Role type
Senior Pharmacovigilance Scientist
Builds
Safety surveillance activities, signal detection, risk management, and regulatory reporting for CSL medicines worldwide.
Domain
Pharmaceutical industry, Pharmacovigilance, Clinical Safety
Required skills
Pharmacovigilance methodology, signal detection, safety data analysis, regulatory reporting, benefit-risk evaluation, literature review, case adjudication, strategic input for safety reports, cross-functional collaboration, mentoring
Preferred skills
Safety monitoring, ICH GCP knowledge, drug development experience, advanced database entry and graphics presentations
Technologies
Microsoft Excel
Responsibilities
Lead safety review process and evaluation of safety data throughout the product lifecycle; Perform end-to-end signal detection and analysis activities on safety data sets; Review scientific and medical literature for important safety information; Provide strategic input to aggregate safety reports (ASRs, PSURs, DSURs, PADERs, RMPs); Organize and provide insights to internal Safety Management Teams; Support product development teams with PV expertise; Develop response strategies for safety-related questions; Mentor junior PV team members.
Seniority
Senior, hands-on IC with mentorship responsibilities