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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Pharmacovigilance and case management within clinical trials, ensuring compliance with GxP regulations and effective management of safety reporting processes. Proficient in developing and overseeing pharmacovigilance procedures, regulatory reporting, and vendor management.
Highest-signal resume keywords
Pharmacovigilance ExperienceGxP ComplianceRegulatory InspectionsSafety Reporting PlansData Management
ATS Keywords
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Hard Skills
Case ManagementSafety Data AnalysisEvent CodingCAPA ManagementSOP DevelopmentRegulatory ReportingKPI MonitoringClinical Trial DocumentationPharmacovigilance ProceduresData Set Administration
Soft Skills
Cross-Functional CollaborationTraining DevelopmentVendor ManagementCommunication
Tools & Technologies
Drug Safety DatabaseRegulatory Software Applications
Industry Keywords
GxP GuidelinesPharmaceutical IndustryClinical TrialsInternational RegulationsPrivacy Protection Requirements
About the role
Key responsibilities & impact- Act as Case Management subject matter expert in cross-functional teams for assigned clinical trials
- Manage case management activities for assigned clinical studies to ensure compliance with national and international regulations, GxP guidelines, legislation, guidance, and company policies
- Manage delivery of Safety Reporting Plans and identify, implement, and monitor KPIs/KQIs across clinical case management activities
- Support preparation and conduct of PV and other GxP inspections and audits
- Establish, maintain, and ensure maintenance of clinical trial case management documents, including safety reporting plans and reporting responsibilities
- Oversee vendors processing SAE, AESI, and pregnancy clinical trial cases and ensure expedited reporting compliance
- Act as primary contact for external vendors regarding GSPV PV Operations clinical trial queries
- Prepare and provide study-specific training to external vendors and GSPV team members
- Participate in drug safety database enhancements and upgrades from a clinical trial perspective
- Develop, implement, and oversee pharmacovigilance procedures and processes
- Ensure uniform and timely processing and analysis of safety data for regulatory compliance
- Ensure correct coding of event and drug terms
- Ensure inter- and intra-consistency for case evaluations
- Lead or oversee ICSR reporting compliance analyses and associated CAPAs
- Liaise internally and with external collaborators to develop regulatory reporting processes
- Oversee preparation of Suspected Unexpected Serious Adverse Reactions for submission to external regulatory agencies
- Lead or contribute to cross-functional projects to fulfill GxP requirements and improve inspection readiness
Requirements
What you’ll need- Bachelor's degree or equivalent in a life science discipline (e.g., nursing, biological sciences, pharmaceutical sciences, or Medical Documentation)
- 7+ years of Pharmacovigilance experience in a multinational pharmaceutical industry environment
- Expert knowledge of local and international regulations and PV processes
- Knowledge of local and international GxP regulations, IT standards, and other relevant legislation, including privacy protection requirements
- Experience with regulatory inspections
- Experience administering complex data sets
- Experience managing CAPA and SOP development projects
- Experience with relevant software applications
- Experience working within a GxP-regulated environment
- Master's or PhD in Life Sciences preferred
Benefits
Comp & perks- CSL benefits are available; details provided via “How CSL Supports Your Well-being | CSL”
- Inclusion and Belonging culture
- Reasonable accommodation for applicants with disabilities