Senior Pharmacovigilance Scientist - Safety Data Leader

CSL; King of Prussia (PA); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

CSL seeks a Senior Pharmacovigilance Scientist (f/m/d) for post-marketing products in King of Prussia, PA. This role leads safety reviews across the product lifecycle, performing end-to-end signal detection and analysis of safety data from diverse sources.

The position includes reviewing literature for important safety information, contributing to ASRs and risk management plans, and collaborating with cross-functional safety teams to address regulatory requests.

Formación

• Bachelor’s degree in pharmaceutical, nursing, biological, or sciences preferred (Medicine and Pharmacy).
• Minimum 3 years in Pharmacovigilance or related field.
• Knowledge of safety monitoring, signal detection, and regulatory standards is expected.
• Strong English written and verbal communication skills.
• Ability to work independently and in cross-functional teams.

Responsabilidades

• Lead safety review process and evaluation of safety data throughout the product lifecycle with GSL support.
• Conduct end-to-end signal detection and analysis on multiple safety data sources and present summaries.
• Review literature for safety information for ASRs and other safety reports.
• Provide strategic input to PSURs, DSURs, PADERs, and risk management plans.
• Organize insights for cross-functional Safety Management Teams (SMTs).
• Support development teams with PV expertise related to clinical data.
• Develop response strategies for safety questions from internal or regulatory sources.
• Mentor junior PVS staff and assist with onboarding and day-to-day tasks.
• Assist with case adjudication, document reviews (IBs, CSRs), SOP updates, and SME support.

Conocimientos

Pharmacovigilance

Signal detection

Regulatory knowledge

English communication

Cross-functional collaboration

Educación

Bachelor’s degree or equivalent in pharmaceutical/biological sciences

Herramientas

Excel

Descripción del empleo

CSL seeks a Senior Pharmacovigilance Scientist (f/m/d) for post-marketing products in King of Prussia, PA. This role leads safety reviews across the product lifecycle, performing end-to-end signal detection and analysis of safety data from diverse sources.

The position includes reviewing literature for important safety information, contributing to ASRs and risk management plans, and collaborating with cross-functional safety teams to address regulatory requests.