Senior Pharmacovigilance Case Manager, Global Trials

CSL

King of Prussia (PA)

Hybrid

USD 110,000 - 140,000

Full time

14 days+

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Job summary

CSL Behring is seeking a Case Management Subject Matter Expert to lead pharmacovigilance activities for assigned clinical trials. You will ensure compliance with GxP and international regulations, maintain critical PV documents, and oversee external vendors for SAE/AESI processing and expedited reporting.

The role requires 7+ years in pharmacovigilance, strong regulatory knowledge, and experience with inspections.

Qualifications

Bachelor's degree in life sciences or allied field; advanced degree preferred.
7+ years of pharmacovigilance experience in a multinational environment.
Expert knowledge of local and international regulations and PV processes.
Knowledge of GxP regulations, IT standards, privacy requirements.
Experience with regulatory inspections.
Experience administering complex datasets.
Experience leading CAPA and SOP development projects.
Experience with relevant software applications; GxP environment experience.

Responsibilities

Serve as Case Management SME in cross-functional trials.
Manage case management activities to ensure compliance with national and international regulations.
Develop and maintain PV procedures and processes; ensure timely safety data processing and analysis.
Lead or contribute to cross-functional projects to meet GxP requirements and inspection readiness.
Oversee regulator reporting (ICSR) and CAPAs from vendors.