Senior Pharmacovigilance Scientist – Post‑Marketing Safety

CSL; Melbourne; Vor Ort; AUD 120.000 - 160.000; Vollzeit

Zusammenfassung

CSL Behring is seeking a Senior Pharmacovigilance Scientist (f/m/d) to lead the safety review process across the product lifecycle for post-marketing products in a global context. The role collaborates with the Global Safety Lead and cross-functional Safety Management Teams to ensure high-quality safety analyses and regulatory submissions.

The candidate will review literature for safety signals, support various Safety Update Reports, and coach junior team members while contributing to regulatory

Qualifikationen

• Bachelor’s or equivalent degree in the pharmaceutical, nursing or biological, or sciences (Degree in Medicine and Pharmacy is preferred)
• At least 3 years’ experience as a Pharmacovigilance scientist or equivalent position
• Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines, and standards
• Excellent written and verbal communication skills in English

Aufgaben

• Lead the safety review process and evaluation of safety data throughout the product lifecycle with Global Safety Lead
• Perform end-to-end signal detection and analysis on safety data sets from various sources
• Review publications for important safety information for use in analyses or RSAs
• Provide strategic input to RSAs (PSURs, DSURs, PADERs, Risk Management Plans)
• Mentor junior PVS members and assist with onboarding

Kenntnisse

English communication

Self-motivation

Analytical thinking

Ausbildung

Pharmaceutical/biological sciences degree

Medicine and Pharmacy degree preferred

Tools

MS Excel

Jobbeschreibung

CSL Behring is seeking a Senior Pharmacovigilance Scientist (f/m/d) to lead the safety review process across the product lifecycle for post-marketing products in a global context. The role collaborates with the Global Safety Lead and cross-functional Safety Management Teams to ensure high-quality safety analyses and regulatory submissions.

The candidate will review literature for safety signals, support various Safety Update Reports, and coach junior team members while contributing to regulatory