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- Tasks: Oversee quality and compliance of Individual Case Safety Reports in a hybrid work environment.
- Company: Join CSL Behring, a leader in innovative healthcare solutions.
- Benefits: Enjoy a flexible work schedule, competitive salary, and a commitment to inclusion.
- Why this job: Make a real impact on patient safety and contribute to groundbreaking medical advancements.
- Qualifications: Experience in pharmacovigilance and strong knowledge of regulatory standards required.
- Other info: Be part of a diverse team dedicated to innovation and patient care.
The predicted salary is between 43200 - 72000 £ 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 Quality Manager (m/f/d) in Reading employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Manager (m/f/d) in Reading
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those connected to CSL Behring. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by diving deep into ICSR quality strategies and global pharmacovigilance practices. We want you to shine when discussing how your experience aligns with the role!
✨Tip Number 3
Showcase your problem-solving skills! Think of examples where you've managed vendor relationships or resolved issues in case management. This will demonstrate your fit for the oversight responsibilities.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Quality Manager (m/f/d) in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Quality Manager role. Highlight your experience with ICSR accountability and any relevant 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, as this will resonate with us.
Showcase Your Regulatory Knowledge: Since global regulatory knowledge is key for this role, make sure to mention any relevant certifications or experiences. We’re looking for someone who understands the ins and outs of compliance, so don’t hold back on showcasing your expertise!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at CSL Behring!
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
Prepare examples of how you've successfully managed vendor relationships in the past. Be ready to discuss specific challenges you've faced and how you resolved them. This will highlight your ability to oversee case management vendors effectively and ensure compliance with quality standards.
✨Showcase Your Audit Experience
If you've been involved in audits or inspections, be sure to mention this during your interview. Discuss your role in supporting these processes and any corrective actions you contributed to. This will demonstrate your hands-on experience and commitment to maintaining high-quality standards.
✨Emphasise Your Teamwork and Inclusion Mindset
CSL values inclusion and belonging, so be prepared to talk about how you've fostered a collaborative environment in your previous roles. Share examples of how you've worked with diverse teams and supported others in achieving common goals. This will resonate well with their company culture and mission.