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- Tasks: Oversee quality management of Individual Case Safety Reports and vendor operations.
- Company: Join CSL Behring, a leader in innovative healthcare solutions.
- Benefits: Enjoy a hybrid work model, competitive salary, and a focus on inclusion.
- Why this job: Make a real impact in patient safety and quality management.
- Qualifications: Experience in pharmacovigilance and knowledge of regulatory compliance required.
- Other info: Be part of a diverse team driving innovation in healthcare.
The predicted salary is between 36000 - 60000 £ per year.
Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality, you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products. This is a hybrid role, which offers a combination of an onsite and remote work schedule.
Responsibilities include:
- Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to governance, financials, contracts, quality and training, and resourcing.
- Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
- Oversee case management vendor(s) to manage and resolve emerging issues.
- Contributes to ICSR quality strategy.
- Responsible for Global ICSR Reconciliation activities.
- Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required.
Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. 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.
Senior Manager, Quality Management in Reading employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Quality Management in Reading
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at CSL or similar companies. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for the interview by diving deep into ICSR quality management. Brush up on your knowledge of global pharmacovigilance regulations and be ready to discuss how you can contribute to CSL's mission.
✨Tip Number 3
Showcase your problem-solving skills! Be ready to share examples of how you've managed vendor relationships and resolved issues in past roles. This will highlight your fit for overseeing case management vendors.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining the CSL team.
We think you need these skills to ace Senior Manager, Quality Management in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Manager, Quality Management role. Highlight your experience with ICSR accountability and any oversight of pharmacovigilance vendors. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management in pharmacovigilance. Share specific examples of how you've contributed to quality strategies in the past – we love a good story!
Showcase Your Regulatory Knowledge: Since this role requires knowledge of global and local regulatory rules, make sure to mention any relevant experience you have. We’re looking for someone who can navigate these waters smoothly, so don’t hold back on your expertise!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to showcase your application in the best light. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at CSL Behring
✨Know Your ICSR Inside Out
Make sure you have a solid understanding of Individual Case Safety Reports (ICSRs) and their significance in pharmacovigilance. Brush up on the latest regulations and guidelines, as well as any recent developments in the field. This will show your potential employer that you're not just familiar with the basics but are genuinely passionate about quality management.
✨Demonstrate Vendor Management Skills
Since this role involves oversight of Global Case Management Pharmacovigilance vendors, be prepared to discuss your experience in managing vendor relationships. Think of specific examples where you've successfully navigated challenges or improved processes. Highlight your ability to ensure compliance and quality in outsourced activities.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations related to case management or vendor issues. Prepare by thinking through potential scenarios and your approach to resolving them. This will help you demonstrate your problem-solving skills and strategic thinking, which are crucial for this role.
✨Showcase Your Audit Experience
As audits and inspections are part of the job, be ready to talk about your experience with these processes. Discuss any CAPAs you've contributed to and how you've ensured compliance in previous roles. This will illustrate your attention to detail and commitment to maintaining high-quality standards.