Senior Clinical Trial Case Manager
Core
Subject matter expert managing case management activities, safety reporting plans, and pharmacovigilance procedures for assigned clinical trials to ensure regulatory compliance.
Role type
Senior Clinical Trial Case Manager (Pharmacovigilance)
Builds
Safety reporting plans, ICSR reports, CAPAs, and regulatory submission documents for clinical trials.
Domain
Life Sciences / Clinical Trials / Pharmacovigilance
Deliverable
client delivery
Required skills
Expert knowledge of GxP regulations, experience administering complex data sets, experience managing CAPA and SOP development projects, ability to oversee vendor performance, proficiency in drug safety database enhancements, expertise in coding event and drug terms, experience with regulatory inspections.
Preferred skills
Master's or PhD in Life Sciences, experience in multinational pharmaceutical industry environment.
Technologies
Drug safety database applications, GxP-compliant IT systems.
Responsibilities
Manage case management activities for assigned clinical studies, identify and monitor KPIs/KQIs across clinical case management activities, support preparation and conduct of PV and GxP inspections, establish and maintain clinical trial case management documents, oversee vendors to ensure GSPV standards, prepare Suspected Unexpected Serious Adverse Reactions for submission to external regulatory agencies, develop and implement pharmacovigilance procedures, ensure correct coding of event and drug terms, lead cross-functional projects to fulfill GxP requirements.
Seniority
Senior, hands-on IC
