Senior Pharmacovigilance Scientist - Vaccines & Safety

HCF; Melbourne; On-site; AUD 150,000 - 210,000; Full time

Job summary

CSL Behring is seeking a Senior Pharmacovigilance Scientist to join our Global Safety & Pharmacovigilance team in Melbourne. You will lead safety data reviews, perform signal detection, contribute to regulatory reporting, and support risk management across product lifecycles, with collaboration across Development, Medical Affairs, Regulatory Affairs, and Clinical teams.

You will mentor junior PV staff and provide PV expertise for internal and external safety requests, helping ensure patient

Qualifications

• Bachelor’s or equivalent degree in pharmaceutical, nursing or biological sciences; Medicine and Pharmacy degree preferred
• 7+ years' Pharmacovigilance experience in multinational pharmaceutical industry with at least 3 years as a PV scientist or equivalent
• Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines and standards
• Knowledge and experience of safety monitoring and signal detection preferred
• Understanding of ICH GCP and drug development preferred
• Excellent written and verbal communication in English; ability to interpret and synthesize scientific data

Responsibilities

• Lead the safety review process and evaluation of safety data across the product lifecycle with the Global Safety Lead
• Perform end-to-end signal detection and analysis on safety data from various sources and present summaries
• Review publications for safety information for use in ASRs and other reports
• Provide input to PSURs, Development Safety Update Reports, PADERs and Risk Management Plans
• Organize and provide insights to internal cross-functional Safety Management Teams
• Support product development teams with PV expertise relating to clinical data
• Develop response strategies for safety-related questions from internal sources or regulatory requests
• Mentor junior PV team members and assist with onboarding
• Other activities including case adjudication and SOP updates

Skills

Excellent written and verbal comms

Self-motivated

Independence with teamwork

English proficiency

Education

Bachelor’s or equivalent in pharma/nursing/biological sciences; Medicine/Pharmacy preferred

Tools

Microsoft Excel

Job description

CSL Behring is seeking a Senior Pharmacovigilance Scientist to join our Global Safety & Pharmacovigilance team in Melbourne. You will lead safety data reviews, perform signal detection, contribute to regulatory reporting, and support risk management across product lifecycles, with collaboration across Development, Medical Affairs, Regulatory Affairs, and Clinical teams.

You will mentor junior PV staff and provide PV expertise for internal and external safety requests, helping ensure patient