At a Glance
- Tasks: Oversee global pharmacovigilance vendors and ensure quality in case processing.
- Company: CSL Behring, a leader in biotherapeutics dedicated to saving lives.
- Benefits: Hybrid work model, competitive salary, and comprehensive health benefits.
- Other info: Inclusive culture that values diversity and fosters innovation.
- Why this job: Join a mission-driven company making a real impact on patient lives.
- Qualifications: 8+ years in clinical trials and pharmacovigilance; strong regulatory knowledge required.
The predicted salary is between 60000 - 80000 € per year.
The Opportunity:
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.
The Role:
- 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.
- Develop and/or maintain/update existing documents for relevant vendor responsibilities.
- 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.
Your Skills & Abilities:
- BS/BA, RN, Pharmacist, or equivalent.
- Minimum of 8 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.
- Experience working with third parties (e.g., contract service providers) and relationship management.
Sr. Manager, ICSR Quality in Chinatown employer: CSL Behring
CSL Behring is an exceptional employer that prioritises employee well-being and professional growth, offering a hybrid work model that promotes flexibility and work-life balance. With a strong commitment to inclusion and belonging, CSL fosters a collaborative culture where diverse perspectives are valued, ensuring that employees can thrive while contributing to life-saving therapies for patients worldwide. The company also provides comprehensive benefits and opportunities for career advancement, making it an ideal place for those seeking meaningful and rewarding employment in the biotherapeutics field.
StudySmarter Expert Advice🤫
We think this is how you could land Sr. Manager, ICSR Quality in Chinatown
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmacovigilance field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a job opening or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching CSL Behring and their products. Understand their mission and values, and think about how your experience aligns with their goals. This will help you stand out as a candidate who truly gets what they're all about.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to ICSR quality and vendor management. Use the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your expertise effectively.
✨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 genuinely interested in joining the CSL Behring team and contributing to their mission of saving lives.
We think you need these skills to ace Sr. Manager, ICSR Quality in Chinatown
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Senior Manager, ICSR Quality. Highlight your experience in pharmacovigilance and case management, and don’t forget to mention any relevant vendor management skills. We want to see how you fit into our world!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background aligns with our mission at CSL Behring. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Achievements:When detailing your experience, focus on specific achievements rather than just listing duties. Use metrics where possible to demonstrate your impact in previous roles. We’re all about results, so let us know how you’ve made a difference!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of success. It’s straightforward and ensures your application gets to the right people. Plus, you’ll find all the info you need about the role and our company there!
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 expertise and commitment to quality.
✨Showcase Your Vendor Management Skills
Prepare examples of how you've successfully managed relationships with third-party vendors in the past. Highlight your experience in overseeing operational management and ensuring compliance. This will demonstrate your ability to handle the responsibilities outlined in the job description.
✨Be Ready for Scenario-Based Questions
Expect questions that assess your problem-solving skills, especially regarding emerging issues with case management vendors. Think of specific scenarios where you resolved conflicts or improved processes, and be ready to discuss them in detail.
✨Emphasise Your Teamwork and Leadership Abilities
Since this role involves oversight and collaboration, be prepared to talk about your experience leading teams and working cross-functionally. Share instances where you contributed to a positive team environment or drove initiatives that improved quality and compliance.
