CSL एक वैश्विक जैवप्रौद्योगिकी और स्वास्थ्य सेवा कंपनी है, जो गंभीर और दुर्लभ बीमारियों से जूझ रहे लोगों के लिए जैव-चिकित्सीय उपचार और टीके विकसित करती है। इसके संचालन में CSL Behring शामिल है, जो प्रतिरक्षा-कमी, वंशानुगत रक्तस्रवण विकारों और अल्फा-1 एंटीट्रिप्सिन की कमी के उपचार उपलब्ध कराता है; CSL Seqirus, जो इन्फ्लुएंजा के टीकों का एक प्रमुख प्रदाता है; और CSL Vifor, जिसका ध्यान आयरन की कमी और नेफ्रोलॉजी पर केंद्रित है। एक व्यापक अनुसंधान एवं विकास नेटवर्क के सहयोग से CSL प्लाज़्मा फ्रैक्शनेशन, रिकॉम्बिनेंट प्रोटीन प्रौद्योगिकी, कोशिका और जीन थेरेपी तथा टीकों के क्षेत्रों में काम करती है। मेलबर्न, ऑस्ट्रेलिया में मुख्यालय वाली यह कंपनी 100 से अधिक देशों में मरीजों की सेवा करती है और अनुसंधान, विनिर्माण, स्वास्थ्य सेवा तथा जैवप्रौद्योगिकी के क्षेत्रों में करियर के अवसर प्रदान करती है।
Senior Clinical Trial Case Manager - CSL - King of Prussia, PA
Lead clinical trial pharmacovigilance case management, vendor oversight, safety reporting, and regulatory compliance for CSL Behring’s biotherapeutics programs. The role supports GxP compliance, inspection readiness, and clinical trial safety across multinational teams.
विवरण
- Serve as the case management subject matter expert within cross-functional teams for assigned clinical trials
- Oversee case management activities for assigned studies in accordance with applicable regulations, GxP requirements, legislation, guidance, and company policies
- Deliver Safety Reporting Plans and establish, implement, and monitor KPIs and KQIs for clinical case management activities
- Support the preparation and execution of pharmacovigilance and other GxP inspections and audits
- Create, maintain, and oversee clinical trial case management documentation, including safety reporting plans and reporting responsibilities
- Supervise vendors handling SAE, AESI, and pregnancy cases in clinical trials and verify compliance with expedited reporting requirements
- Serve as the primary contact for external vendors on GSPV PV Operations clinical trial questions
- Develop and deliver study-specific training for external vendors and GSPV team members
- Contribute to drug safety database enhancements and upgrades from a clinical trial perspective
- Develop, implement, and oversee pharmacovigilance procedures and processes
- Maintain consistent, timely safety data processing and analysis to support regulatory compliance
- Verify accurate coding of event and drug terms
- Maintain consistency within and across case evaluations
- Lead or oversee ICSR reporting compliance analyses and related CAPAs
- Work with internal teams and external collaborators to develop regulatory reporting processes
- Oversee preparation of Suspected Unexpected Serious Adverse Reactions for submission to external regulatory agencies
- Lead or support cross-functional initiatives that meet GxP requirements and strengthen inspection readiness
आवश्यकताएँ
- Bachelor’s degree or equivalent in a life sciences field, such as nursing, biological sciences, pharmaceutical sciences, or medical documentation
- At least 7 years of pharmacovigilance experience in a multinational pharmaceutical environment
- Advanced knowledge of local and international regulations and pharmacovigilance processes
- Knowledge of applicable GxP regulations, IT standards, privacy requirements, and related legislation
- Experience supporting regulatory inspections
- Experience managing complex data sets
- Experience leading CAPA and SOP development projects
- Experience using relevant software applications
- Experience working in a GxP-regulated environment
- A master’s degree or PhD in life sciences is preferred
लाभ
- CSL benefits are available, with details provided through “How CSL Supports Your Well-being | CSL”
- Culture focused on inclusion and belonging
- Reasonable accommodations are available for applicants with disabilities