Senior Case Processing Oversight Manager
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Job Location:
Maidenhead - UK
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
The position is part of a team responsible for continuous analysis of global documents and regulatory intelligence from interface functions to decide on relevant updates to regulatory and business reporting requirements.
Key Responsibilities
Oversee follow-up activities to ensure that follow-up of cases is done in accordance with the procedural documents
Oversee the assessment and the handling of literature articles identified by the Global Literature Office and local literature articles identified by the Safety Officers
Serve as case processing Subject Matter Expert (SME) for the input into procedural documents for case processing-related processes (e.g. SOPs GDLs work instructions); SME for incorporating process changes into the training material for case processing and for reviewing it for accuracy.
Collaborate with GSPV and external stakeholders to improve/ optimize case management processes including the development of SOPs and WIs in collaboration with other functions.
Maintain the tracking tool where new process decisions are tracked and ensuring that users are informed.
Supporting the investigation / assessment of ICSR compliance activities where required
Reg Intelligence (RING) assessment to decide on relevant updates or the impact on case processing due to regulatory updates.
Audit and inspection readiness including corrective & preventive action (CAPA) management.
SME for the initiatives or projects in the context of case processing
Skills and Experience Required
Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
Direct experience authoring/ updating SOPs work instructions
Qualifications and Educations Required
BS/BA RN Pharmacist or similar.
Our Benefits
We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL
Do work that matters at CSL Behring!
Required Experience:
Manager
Key Skills
- Project Portfolio Management
- Motivational Interviewing
- HIPAA
- Computer Skills
- Intake Experience
- Lean Six Sigma
- Conflict Management
- Case Management
- Team Management
- Program Development
- Social Work
- Addiction Counseling
About Company
Join the thousands of people who safely donate plasma each week at CSL Plasma and get rewarded for your time.
