Senior Clinical Trial Case Manager
Skills
About the role
This is a senior pharmacovigilance role managing case management activities for clinical trials at CSL, based in King of Prussia, PA. It suits an experienced PV professional who can act as the case management subject-matter expert across cross-functional trial teams. The role oversees vendors, safety reporting compliance, and inspection readiness for assigned studies.
What you’ll do
- Manage case management activities for assigned clinical studies to ensure regulatory compliance
- Oversee vendors processing SAE, AESI and pregnancy cases for expedited reporting compliance
- Lead major incident analysis and post-incident reviews
- Prepare and provide study-specific training to vendors and internal teams
- Oversee preparation of Suspected Unexpected Serious Adverse Reactions for regulatory submission
- Support PV inspections and audits
- Develop and maintain safety reporting plans and related documentation
What they’re looking for
- Bachelor's degree or equivalent in a life science discipline
- 7+ years of pharmacovigilance experience in a multinational pharmaceutical environment
- Expert knowledge of local and international PV regulations and processes
- Experience with regulatory inspections
- Experience administering complex data sets
- Experience managing CAPA and SOP development projects
Nice to have
- Master's or PhD in Life Sciences
Questions about this role
How many years of experience do I need?
The posting asks for 7+ years of pharmacovigilance experience in a multinational pharmaceutical environment.
What degree is required?
A bachelor's degree or equivalent in a life science discipline; a master's or PhD is preferred.
Is this role remote?
No, the posting lists King of Prussia, PA as the location and does not describe remote work.
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