About The Position
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for medical review of ICSRs.
Requirements
- Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience
- Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations
- BS/BA, RN, Pharmacist, or similar
Responsibilities
- Oversight of Case Management Processes activities
- Oversight of Medical Evaluator role which completes medical review of the following ICSRs: All serious cases from all sources Non-serious cases from company-sponsored clinical study, if required Legal ICSRs (serious and non-serious) Reportable cases of combination products with device issue(s) / malfunction (serious and non-serious) Non-serious ICSRs are processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical Evaluator
- Medical review includes: Review of seriousness, listedness and causality assessments Review of event terms and MedDRA coding Review of narrative for medical accuracy and consistency Assessment of the need for Quality Investigations Generation of medical follow up queries / Targeted Questionnaires
- Drive department-wide planning: resource, budget, and org. strategy
- Own case management dashboards and governance scorecards
- Prepare for internal and external inspections including coordination of creation of presentations
- Lead transformation initiatives (e.g., vendor transitions, digital tools)
- Monitor regulatory trends and represent PV case management in global initiatives
- Coordinate departmental leadership meetings and communication
- Pilot innovations (e.g., RPA, AI triage, tech integration)
- Align with Clinical, QA, Regulatory, and Safety Science functions
- Coordinate creation and update of SOPs
- Retain product and process knowledge
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
